<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296527</url>
  </required_header>
  <id_info>
    <org_study_id>000145</org_study_id>
    <nct_id>NCT03296527</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women</brief_title>
  <official_title>A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing&#xD;
      pregnancy rate in women undergoing controlled ovarian stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 26, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing Pregnancy Rate</measure>
    <time_frame>10-11 weeks after transfer</time_frame>
    <description>Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate</measure>
    <time_frame>13-15 days after transfer</time_frame>
    <description>Defined as positive βhCG test 13-15 days after transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>5-6 weeks after transfer</time_frame>
    <description>Defined as at least one gestational sac 5-6 weeks after transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Pregnancy Rate</measure>
    <time_frame>5-6 weeks after transfer</time_frame>
    <description>Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation Rate</measure>
    <time_frame>5-6 weeks after transfer</time_frame>
    <description>Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing Implantation Rate</measure>
    <time_frame>10-11 weeks after transfer</time_frame>
    <description>Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Extreme Ovarian Responses</measure>
    <time_frame>Oocyte retrieval visit</time_frame>
    <description>Extreme ovarian response defined as &lt;4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as &lt;4 oocytes retrieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS</measure>
    <time_frame>Up to 9 days after triggering of final follicular maturation</time_frame>
    <description>Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</measure>
    <time_frame>End-of-stimulation visit (up to 20 days) or transfer visit</time_frame>
    <description>For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Follicles on Stimulation Day 6</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Counted by ultrasound for the right and left ovary for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)</measure>
    <time_frame>At end-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Counted by ultrasound for the right and left ovary for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of Follicles on Stimulation Day 6</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Counted by ultrasound for the right and left ovary for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)</measure>
    <time_frame>At end-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Counted by ultrasound for the right and left ovary for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Oocytes Retrieved</measure>
    <time_frame>On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)</time_frame>
    <description>The number of oocytes retrieved was recorded at the oocyte retrieval visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</measure>
    <time_frame>On the day of oocyte retrieval</time_frame>
    <description>Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the &lt;4 oocytes group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Metaphase II (MII) Oocytes</measure>
    <time_frame>Prior to insemination</time_frame>
    <description>The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilization Rate</measure>
    <time_frame>On Day 1 after oocyte retrieval</time_frame>
    <description>The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Quality of Embryos</measure>
    <time_frame>On Day 3 after oocyte retrieval</time_frame>
    <description>Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Luteinizing Hormone (LH)</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of LH</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Estradiol</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Estradiol</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Progesterone</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Progesterone</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Inhibin A</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Inhibin A</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Inhibin B</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Inhibin B</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of Follicle-stimulating Hormone (FSH)</measure>
    <time_frame>On stimulation Day 6</time_frame>
    <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of FSH</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Concentrations of FSH</measure>
    <time_frame>At oocyte retrieval</time_frame>
    <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Gonadotropin Dose</measure>
    <time_frame>Up to 20 stimulation days</time_frame>
    <description>Calculated by start dates, end dates and daily dose of IMP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments</measure>
    <time_frame>Up to 20 stimulation days</time_frame>
    <description>Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Stimulation Days</measure>
    <time_frame>Up to 20 stimulation days</time_frame>
    <description>Calculated by start dates and end dates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
    <description>Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Adverse Events</measure>
    <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
    <description>The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase</measure>
    <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate</measure>
    <time_frame>End-of-stimulation visit and end-of-trial visit</time_frame>
    <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Erythrocytes</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameters: Leukocytes and Platelets</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Haemoglobin</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Haematocrit</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Haematocrit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes</measure>
    <time_frame>End-of-stimulation visit and end-of-trial visit</time_frame>
    <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Immune-related Adverse Events</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Injection Site Reactions</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Injection Site Reactions</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity</measure>
    <time_frame>Up to 28 days after end of the stimulation period</time_frame>
    <description>Measured by presence of anti-FSH antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of Immune-related Adverse Events</measure>
    <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
    <description>The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen</measure>
    <time_frame>Up to 20 stimulation days</time_frame>
    <description>For each participant the reason for cycle cancellation will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Late OHSS</measure>
    <time_frame>After 9 days post triggering of final follicular maturation</time_frame>
    <description>Late OHSS was defined as OHSS with onset &gt;9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Multi-fetal Gestation</measure>
    <time_frame>End-of-trial</time_frame>
    <description>Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Early Pregnancy Losses</measure>
    <time_frame>End-of-trial</time_frame>
    <description>Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).&#xD;
Frequency of early pregnancy losses are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Technical Malfunctions of the Administration Pen</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Incidences of technical malfunctions of the administration pen were recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1011</enrollment>
  <condition>Controlled Ovarian Simulation</condition>
  <arm_group>
    <arm_group_label>Follitropin delta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gonal-F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rFSH. Follitropin alfa for subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin alfa</intervention_name>
    <description>GONAL-F dose was fixed for the first 5 stimulation days.</description>
    <arm_group_label>Gonal-F</arm_group_label>
    <other_name>GONAL-F</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin delta</intervention_name>
    <description>REKOVELLE (FE 999049) was fixed throughout the stimulation period.</description>
    <arm_group_label>Follitropin delta</arm_group_label>
    <other_name>FE 999049</other_name>
    <other_name>REKOVELLE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Documents signed prior to screening evaluations.&#xD;
&#xD;
          -  In good physical and mental health in the judgement of the investigator.&#xD;
&#xD;
          -  Asian pre-menopausal females between the ages of 20 and 40 years. The participants&#xD;
             must be at least 20 years (including the 20th birthday) when they sign the informed&#xD;
             consent and no more than 40 years (up to the day before the 41st birthday) at the time&#xD;
             of randomization.&#xD;
&#xD;
          -  Infertile women diagnosed with tubal infertility, unexplained infertility,&#xD;
             endometriosis stage I/II (defined by the revised American Society for Reproductive&#xD;
             Medicine [ASRM] classification, 1996) or with partners diagnosed with male factor&#xD;
             infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm&#xD;
             injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm&#xD;
             donor.&#xD;
&#xD;
          -  Infertility for at least one year before randomization for participants &lt;35 years or&#xD;
             for at least 6 months for participants ≥35 years (not applicable in case of tubal or&#xD;
             severe male factor infertility).&#xD;
&#xD;
          -  The trial cycle will be the participant's first controlled ovarian stimulation cycle&#xD;
             for IVF/ICSI.&#xD;
&#xD;
          -  Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.&#xD;
&#xD;
          -  Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal&#xD;
             ultrasound documenting a uterus consistent with expected normal function (e.g. no&#xD;
             evidence of clinically interfering uterine fibroids defined as submucous or intramural&#xD;
             fibroids larger than 3 cm in diameter, no polyps and no congenital structural&#xD;
             abnormalities which are associated with a reduced chance of pregnancy) within 1 year&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Transvaginal ultrasound documenting presence and adequate visualisation of both&#xD;
             ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which&#xD;
             would contraindicate the use of gonadotropins) and normal adnexa (e.g. no&#xD;
             hydrosalpinx) within 1 year prior to randomization. Both ovaries must be accessible&#xD;
             for oocyte retrieval.&#xD;
&#xD;
          -  Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L&#xD;
             (results obtained within 3 months prior to randomization).&#xD;
&#xD;
          -  Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human&#xD;
             Immunodeficiency Virus (HIV) antibody tests within 2 years prior to randomization.&#xD;
&#xD;
          -  Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.&#xD;
&#xD;
          -  Willing to accept transfer of 1-2 embryos.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).&#xD;
&#xD;
          -  One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound&#xD;
             prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to&#xD;
             randomization).&#xD;
&#xD;
          -  Known history of recurrent miscarriage (defined as three consecutive losses after&#xD;
             ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of&#xD;
             pregnancy).&#xD;
&#xD;
          -  Known abnormal karyotype of participant or of her partner / sperm donor, as&#xD;
             applicable, depending on source of sperm used for insemination in this trial.&#xD;
&#xD;
          -  Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).&#xD;
&#xD;
          -  Known inherited or acquired thrombophilia disease.&#xD;
&#xD;
          -  Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of&#xD;
             these events.&#xD;
&#xD;
          -  Known porphyria.&#xD;
&#xD;
          -  Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or&#xD;
             kidney) with the exception of controlled thyroid function disease.&#xD;
&#xD;
          -  Known presence of anti-FSH antibodies (based on the information available in the&#xD;
             participant's medical records; i.e. not based on the anti-FSH antibody analyses&#xD;
             conducted in the trial).&#xD;
&#xD;
          -  Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus&#xD;
             which would contraindicate the use of gonadotropins.&#xD;
&#xD;
          -  Known moderate or severe impairment of renal or hepatic function.&#xD;
&#xD;
          -  Any abnormal finding of clinical chemistry, haematology or vital signs at screening&#xD;
             which is clinically significant as judged by the investigator.&#xD;
&#xD;
          -  Currently breast-feeding.&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding.&#xD;
&#xD;
          -  Known abnormal cervical cytology of clinical significance observed within three years&#xD;
             prior to randomization (unless the clinical significance has been resolved).&#xD;
&#xD;
          -  Findings at the gynaecological examination at screening which preclude gonadotropin&#xD;
             stimulation or are associated with a reduced chance of pregnancy, e.g. congenital&#xD;
             uterine abnormalities or retained intrauterine device.&#xD;
&#xD;
          -  Pregnancy (negative urinary pregnancy tests must be documented at screening and prior&#xD;
             to randomization) or contraindication to pregnancy.&#xD;
&#xD;
          -  Known current active pelvic inflammatory disease.&#xD;
&#xD;
          -  Use of fertility modifiers during the last menstrual cycle before randomization,&#xD;
             including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral&#xD;
             contraceptives, progestogen or estrogen preparations.&#xD;
&#xD;
          -  Use of hormonal preparations (except for thyroid medication) during the last menstrual&#xD;
             cycle before randomization.&#xD;
&#xD;
          -  Known history of chemotherapy (except for gestational conditions) or radiotherapy.&#xD;
&#xD;
          -  Current or past (1 year prior to randomization) abuse of alcohol or drugs.&#xD;
&#xD;
          -  Current (last month) intake of more than 14 units of alcohol per week.&#xD;
&#xD;
          -  Current or past (3 months prior to randomization) smoking habit of more than 10&#xD;
             cigarettes per day.&#xD;
&#xD;
          -  Hypersensitivity to any active ingredient or excipients in the medicinal products used&#xD;
             in the trial.&#xD;
&#xD;
          -  Previous participation in the trial.&#xD;
&#xD;
          -  Use of any non-registered investigational drugs during the last 3 months prior to&#xD;
             randomization.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Obstetrics and Gynecology Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for Human Reproduction, Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Second University Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of An'hui Medical University</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ShengJing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Central Hospital of Gynaecology and Obstetrics</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital,Tongji Medical College, Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center for Assisted Reproductive Technology</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>My Duc Hospital</name>
      <address>
        <city>Ho Chi Minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
    <country>Vietnam</country>
  </location_countries>
  <results_reference>
    <citation>Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, Goethberg M, Mannaerts B, Arce JC. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Aug 18;36(9):2452-2462. doi: 10.1093/humrep/deab155.</citation>
    <PMID>34179971</PMID>
  </results_reference>
  <results_reference>
    <citation>Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, Yang Y, Tan J, Zhang Q, Sun Y, Wang W, Qian W, Jin L, Wang S, Xu Y, Yang J, Goethberg M, Mannaerts B, Wu W, Zheng Z, Qiao J. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022 Oct 4;20(1):147. doi: 10.1186/s12958-022-01016-y.</citation>
    <PMID>36195924</PMID>
  </results_reference>
  <results_reference>
    <citation>Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in &quot;freeze-all&quot; approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.</citation>
    <PMID>37156263</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>April 27, 2021</results_first_submitted>
  <results_first_submitted_qc>May 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2021</results_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Protocol excluding mainland China</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03296527/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Protocol specific for mainland China</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03296527/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03296527/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 26 investigational sites randomized participants to the trial: 16 in mainland China, 4 in South Korea, 4 in Taiwan and 2 in Vietnam between Dec 2017 to Jan 2020.</recruitment_details>
      <pre_assignment_details>A total of 1167 participants were screened, wherein, 1011 participants met the eligibility criteria and were randomized. Of these, 1009 participants were exposed to the investigational medicinal product (IMP): 499 participants were exposed to FE 999049 and 510 participants were exposed to GONAL-F. A total of 923 participants completed the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FE 000049 (Follitropin Delta)</title>
          <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
        </group>
        <group group_id="P2">
          <title>GONAL-F (Follitropin Alfa)</title>
          <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="500"/>
                <participants group_id="P2" count="511"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="499"/>
                <participants group_id="P2" count="510"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="465"/>
                <participants group_id="P2" count="458"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuations due to risk of ovarian hyperstimulation syndrome [OHSS]</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuations due to withdrawal from trial</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuations due to thin endometrium or poor endometrial receptivity</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuation due to liquid in uterus</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuation due to risk of Human Immunodeficiency Virus</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set (FAS) was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>FE 000049 (Follitropin Delta)</title>
          <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
        </group>
        <group group_id="B2">
          <title>GONAL-F (Follitropin Alfa)</title>
          <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="499"/>
            <count group_id="B2" value="510"/>
            <count group_id="B3" value="1009"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.1" spread="3.7"/>
                    <measurement group_id="B2" value="31.2" spread="3.8"/>
                    <measurement group_id="B3" value="31.1" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="394"/>
                    <measurement group_id="B2" value="396"/>
                    <measurement group_id="B3" value="790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35-37</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>38-40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="499"/>
                    <measurement group_id="B2" value="510"/>
                    <measurement group_id="B3" value="1009"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="499"/>
                    <measurement group_id="B2" value="510"/>
                    <measurement group_id="B3" value="1009"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Chinese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="379"/>
                    <measurement group_id="B2" value="381"/>
                    <measurement group_id="B3" value="760"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vietnamese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="378"/>
                    <measurement group_id="B2" value="381"/>
                    <measurement group_id="B3" value="759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vietnam</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.8" spread="2.7"/>
                    <measurement group_id="B2" value="21.8" spread="2.8"/>
                    <measurement group_id="B3" value="21.8" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ongoing Pregnancy Rate</title>
        <description>Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.</description>
        <time_frame>10-11 weeks after transfer</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Ongoing Pregnancy Rate</title>
          <description>Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3"/>
                    <measurement group_id="O2" value="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of participants with ongoing pregnancy rate</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.</non_inferiority_desc>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>5.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>11.0</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate</title>
        <description>Defined as positive βhCG test 13-15 days after transfer.</description>
        <time_frame>13-15 days after transfer</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate</title>
          <description>Defined as positive βhCG test 13-15 days after transfer.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                    <measurement group_id="O2" value="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of participants with positive beta-hCG</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3</ci_lower_limit>
            <ci_upper_limit>12.3</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Pregnancy Rate</title>
        <description>Defined as at least one gestational sac 5-6 weeks after transfer.</description>
        <time_frame>5-6 weeks after transfer</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Pregnancy Rate</title>
          <description>Defined as at least one gestational sac 5-6 weeks after transfer.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1"/>
                    <measurement group_id="O2" value="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of participants with at least one gestational sac 5-6 weeks after transfer</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vital Pregnancy Rate</title>
        <description>Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.</description>
        <time_frame>5-6 weeks after transfer</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Vital Pregnancy Rate</title>
          <description>Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3"/>
                    <measurement group_id="O2" value="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implantation Rate</title>
        <description>Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.</description>
        <time_frame>5-6 weeks after transfer</time_frame>
        <population>Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Implantation Rate</title>
          <description>Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.</description>
          <population>Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo.</population>
          <units>percentage of sacs/embryos transferred</units>
          <param>Number</param>
          <units_analyzed>Embryos transferred</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Embryos transferred</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="548"/>
                <count group_id="O2" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of implanted embryos 5-6 weeks after transfer</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>9.5</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ongoing Implantation Rate</title>
        <description>Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.</description>
        <time_frame>10-11 weeks after transfer</time_frame>
        <population>Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Ongoing Implantation Rate</title>
          <description>Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.</description>
          <population>Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos.</population>
          <units>% of viable fetus/embryos transferred</units>
          <param>Number</param>
          <units_analyzed>Embryos transferred</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Embryos transferred</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="548"/>
                <count group_id="O2" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.7"/>
                    <measurement group_id="O2" value="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of participants with ongoing implantation rate</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>9.7</ci_upper_limit>
            <estimate_desc>The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Extreme Ovarian Responses</title>
        <description>Extreme ovarian response defined as &lt;4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as &lt;4 oocytes retrieved.</description>
        <time_frame>Oocyte retrieval visit</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Extreme Ovarian Responses</title>
          <description>Extreme ovarian response defined as &lt;4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as &lt;4 oocytes retrieved.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="495"/>
                <count group_id="O2" value="507"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;4 or &gt;=15 oocytes retrieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3"/>
                    <measurement group_id="O2" value="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;4 or &gt;=20 oocytes retrieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4"/>
                    <measurement group_id="O2" value="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with &lt;4 or &gt;=15 oocytes retrieved</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Logistic regression including AMH group as a factor.</non_inferiority_desc>
            <p_value>0.083</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with &lt;4 or &gt;=20 oocytes retrieved</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Logistic regression including AMH group as a factor.</non_inferiority_desc>
            <p_value>0.489</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS</title>
        <description>Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.</description>
        <time_frame>Up to 9 days after triggering of final follicular maturation</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS</title>
          <description>Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Early OHSS (any grade)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                    <measurement group_id="O2" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (moderate/severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any preventive intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (any grade) and/or preventive interventions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (moderate/severe) and/or preventive interventions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with early OHSS (any grade)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.075</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.34</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with early OHSS (moderate/severe)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.365</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with any preventive intervention</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.012</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with early OHSS (any grade) and/or preventive interventions</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.004</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.029</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</title>
        <description>For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.</description>
        <time_frame>End-of-stimulation visit (up to 20 days) or transfer visit</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</title>
          <description>For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle cancellation due to poor response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle cancellation due to excessive response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transfer cancellation due to excessive ovarian response/ OHSS risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                    <measurement group_id="O2" value="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle cancellation: poor/excessive response, or transfer cancellation excessive response/OHSS risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with cycle cancellation due to poor response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.52</ci_lower_limit>
            <ci_upper_limit>13.74</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using a logistic regression model including age stratum as factor.</non_inferiority_desc>
            <p_value>0.020</p_value>
            <p_value_desc>The p-value is based on the likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Odds ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Follicles on Stimulation Day 6</title>
        <description>Counted by ultrasound for the right and left ovary for each participant.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Follicles on Stimulation Day 6</title>
          <description>Counted by ultrasound for the right and left ovary for each participant.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>number of follicles</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="498"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Follicles &gt;= 10 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="3.5"/>
                    <measurement group_id="O2" value="6.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 12 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.2"/>
                    <measurement group_id="O2" value="2.9" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 15 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.7"/>
                    <measurement group_id="O2" value="0.3" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 17 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 10 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 12 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 15 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.568</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 17 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.839</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)</title>
        <description>Counted by ultrasound for the right and left ovary for each participant.</description>
        <time_frame>At end-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)</title>
          <description>Counted by ultrasound for the right and left ovary for each participant.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>number of follicles</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Follicles &gt;= 10 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="5.6"/>
                    <measurement group_id="O2" value="14.2" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 12 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="4.9"/>
                    <measurement group_id="O2" value="11.9" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 15 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="3.2"/>
                    <measurement group_id="O2" value="7.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicles &gt;= 17 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="1.8"/>
                    <measurement group_id="O2" value="4.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 10 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 12 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 15 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of follicles &gt;= 17 mm</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Size of Follicles on Stimulation Day 6</title>
        <description>Counted by ultrasound for the right and left ovary for each participant.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Size of Follicles on Stimulation Day 6</title>
          <description>Counted by ultrasound for the right and left ovary for each participant.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="461"/>
                <count group_id="O2" value="493"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Largest follicle (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="461"/>
                    <count group_id="O2" value="493"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="2.0"/>
                    <measurement group_id="O2" value="13.2" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average follicle size (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="461"/>
                    <count group_id="O2" value="493"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="1.0"/>
                    <measurement group_id="O2" value="11.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average size of 3 largest follicles (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="393"/>
                    <count group_id="O2" value="441"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="1.6"/>
                    <measurement group_id="O2" value="12.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Largest follicle (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.140</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Average follicle size (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.155</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment comparison: Average size of 3 largest follicles (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.159</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)</title>
        <description>Counted by ultrasound for the right and left ovary for each participant.</description>
        <time_frame>At end-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)</title>
          <description>Counted by ultrasound for the right and left ovary for each participant.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="490"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Largest follicle (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="490"/>
                    <count group_id="O2" value="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="1.9"/>
                    <measurement group_id="O2" value="19.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average follicle size (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="490"/>
                    <count group_id="O2" value="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="1.3"/>
                    <measurement group_id="O2" value="15.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average size of 3 largest follicles (mm)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="482"/>
                    <count group_id="O2" value="505"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6" spread="1.4"/>
                    <measurement group_id="O2" value="18.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Largest follicle (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.848</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Average follicle size (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.629</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Average size of 3 largest follicles (mm)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.768</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Oocytes Retrieved</title>
        <description>The number of oocytes retrieved was recorded at the oocyte retrieval visit.</description>
        <time_frame>On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Oocytes Retrieved</title>
          <description>The number of oocytes retrieved was recorded at the oocyte retrieval visit.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>oocytes retrieved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="6.1"/>
                    <measurement group_id="O2" value="12.4" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mean number of oocytes retrieved</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</title>
        <description>Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the &lt;4 oocytes group.</description>
        <time_frame>On the day of oocyte retrieval</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</title>
          <description>Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the &lt;4 oocytes group.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="495"/>
                <count group_id="O2" value="507"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;4 (low response)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 -7 (moderate response)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0"/>
                    <measurement group_id="O2" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-14 (targeted response)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15-19(hyperresponse)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                    <measurement group_id="O2" value="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=20 (severe hyperresponse)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                    <measurement group_id="O2" value="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Metaphase II (MII) Oocytes</title>
        <description>The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.</description>
        <time_frame>Prior to insemination</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with all oocytes inseminated using ICSI.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Metaphase II (MII) Oocytes</title>
          <description>The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with all oocytes inseminated using ICSI.</population>
          <units>percentage of oocytes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5" spread="17.6"/>
                    <measurement group_id="O2" value="77.8" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of MII oocytes / oocytes retrieved</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.197</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fertilization Rate</title>
        <description>The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.</description>
        <time_frame>On Day 1 after oocyte retrieval</time_frame>
        <population>Participants with oocytes retrieved.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Fertilization Rate</title>
          <description>The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.</description>
          <population>Participants with oocytes retrieved.</population>
          <units>percentage of fertilized oocytes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="477"/>
                <count group_id="O2" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5" spread="22.9"/>
                    <measurement group_id="O2" value="63.9" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fertilization rate relative to oocytes retrieved</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.790</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Quality of Embryos</title>
        <description>Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.</description>
        <time_frame>On Day 3 after oocyte retrieval</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Quality of Embryos</title>
          <description>Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>embryos</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of embryos</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="4.6"/>
                    <measurement group_id="O2" value="8.7" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of good-quality embryos</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="3.6"/>
                    <measurement group_id="O2" value="5.2" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of embryos on day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of good-quality embryos on Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value based on van Elteren test adjusted for age stratum.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Luteinizing Hormone (LH)</title>
        <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Luteinizing Hormone (LH)</title>
          <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>IU/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="496"/>
                <count group_id="O2" value="508"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.7" upper_limit="4.7"/>
                    <measurement group_id="O2" value="3.1" lower_limit="1.9" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of LH on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of LH</title>
        <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of LH</title>
          <description>Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>IU/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="492"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.1" upper_limit="2.9"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.2" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of LH at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.018</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Estradiol</title>
        <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Estradiol</title>
          <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>pmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="497"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2240.7" lower_limit="1325.8" upper_limit="3641.1"/>
                    <measurement group_id="O2" value="2885.9" lower_limit="1729.4" upper_limit="4492.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Estradiol on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Estradiol</title>
        <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Estradiol</title>
          <description>Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>pmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="491"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7429.3" lower_limit="4786.2" upper_limit="10439.8"/>
                    <measurement group_id="O2" value="9055.8" lower_limit="6214.2" upper_limit="12964.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Estradiol at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Progesterone</title>
        <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Progesterone</title>
          <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="497"/>
                <count group_id="O2" value="507"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.8" upper_limit="2.6"/>
                    <measurement group_id="O2" value="1.9" lower_limit="0.8" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Progesterone on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>The p-value corresponds to the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean Ratio</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Progesterone</title>
        <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Progesterone</title>
          <description>Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>nmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="490"/>
                <count group_id="O2" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="1.7" upper_limit="3.5"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.2" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Progesterone at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Inhibin A</title>
        <description>Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Inhibin A</title>
          <description>Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>ng/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="496"/>
                <count group_id="O2" value="508"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.9" lower_limit="61.6" upper_limit="163.5"/>
                    <measurement group_id="O2" value="129.1" lower_limit="84.6" upper_limit="203.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Inhibin A on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Inhibin A</title>
        <description>Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Inhibin A</title>
          <description>Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>ng/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="491"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="361.7" lower_limit="252.8" upper_limit="525.6"/>
                    <measurement group_id="O2" value="447.4" lower_limit="307.5" upper_limit="630.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Inhibin A at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Inhibin B</title>
        <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Inhibin B</title>
          <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>ng/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="445"/>
                <count group_id="O2" value="452"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="740.0" lower_limit="481.0" upper_limit="1069.0"/>
                    <measurement group_id="O2" value="901.0" lower_limit="588.0" upper_limit="1317.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Inhibin B on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Inhibin B</title>
        <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Inhibin B</title>
          <description>Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>ng/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="445"/>
                <count group_id="O2" value="449"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1020.0" lower_limit="689.0" upper_limit="1488.0"/>
                    <measurement group_id="O2" value="1101.0" lower_limit="738.0" upper_limit="1665.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of Inhibin B at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of Follicle-stimulating Hormone (FSH)</title>
        <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.</description>
        <time_frame>On stimulation Day 6</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of Follicle-stimulating Hormone (FSH)</title>
          <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>IU/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="497"/>
                <count group_id="O2" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="9.5" upper_limit="14.8"/>
                    <measurement group_id="O2" value="11.2" lower_limit="9.5" upper_limit="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of FSH on stimulation Day 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of FSH</title>
        <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of FSH</title>
          <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>IU/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="491"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" lower_limit="9.2" upper_limit="14.4"/>
                    <measurement group_id="O2" value="12.2" lower_limit="10.4" upper_limit="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of FSH at end-of-stimulation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The p-value corresponds to F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Concentrations of FSH</title>
        <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.</description>
        <time_frame>At oocyte retrieval</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Concentrations of FSH</title>
          <description>Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>IU/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="478"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="4.5" upper_limit="7.1"/>
                    <measurement group_id="O2" value="5.5" lower_limit="4.4" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating concentrations of FSH at oocyte retrieval visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.184</p_value>
            <p_value_desc>The p-value corresponds to the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The multiplicative ANCOVA model included treatment and age stratum as fixed factors.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/GONAL-F.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Gonadotropin Dose</title>
        <description>Calculated by start dates, end dates and daily dose of IMP.</description>
        <time_frame>Up to 20 stimulation days</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Gonadotropin Dose</title>
          <description>Calculated by start dates, end dates and daily dose of IMP.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>microgram of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" spread="24.4"/>
                    <measurement group_id="O2" value="109.9" spread="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Total gonadotropin dose</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>van Elteren test</method>
            <method_desc>p-value is based on van Elteren test adjusted for AMH group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments</title>
        <description>Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.</description>
        <time_frame>Up to 20 stimulation days</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments</title>
          <description>Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                    <measurement group_id="O2" value="55.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Stimulation Days</title>
        <description>Calculated by start dates and end dates.</description>
        <time_frame>Up to 20 stimulation days</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Stimulation Days</title>
          <description>Calculated by start dates and end dates.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="1.9"/>
                    <measurement group_id="O2" value="8.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of stimulation days</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment groups were compared using the van Elteren test.</non_inferiority_desc>
            <p_value>0.001</p_value>
            <method>van Elteren</method>
            <method_desc>p-value is based on van Elteren test adjusted for AMH group.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.</description>
        <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="449"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3"/>
                    <measurement group_id="O2" value="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Adverse Events</title>
        <description>The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
        <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Adverse Events</title>
          <description>The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.1"/>
                    <measurement group_id="O2" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4"/>
                    <measurement group_id="O2" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase</title>
        <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.</description>
        <time_frame>From screening up to end-of-trial (up to approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase</title>
          <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>IU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="506"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="493"/>
                    <count group_id="O2" value="501"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="13.8"/>
                    <measurement group_id="O2" value="4.6" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="8.2"/>
                    <measurement group_id="O2" value="-2.7" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="490"/>
                    <count group_id="O2" value="496"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="7.1"/>
                    <measurement group_id="O2" value="1.2" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma glutamyl transferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="6.6"/>
                    <measurement group_id="O2" value="1.1" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium</title>
        <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium</title>
          <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="506"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bicarbonate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="493"/>
                    <count group_id="O2" value="503"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="2.52"/>
                    <measurement group_id="O2" value="-0.72" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood urea nitrogen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="1.12"/>
                    <measurement group_id="O2" value="-0.23" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.089"/>
                    <measurement group_id="O2" value="0.000" spread="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.3"/>
                    <measurement group_id="O2" value="-0.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.218" spread="0.537"/>
                    <measurement group_id="O2" value="0.260" spread="0.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="493"/>
                    <count group_id="O2" value="503"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.94"/>
                    <measurement group_id="O2" value="-0.01" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.037" spread="0.166"/>
                    <measurement group_id="O2" value="0.023" spread="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="504"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.34"/>
                    <measurement group_id="O2" value="0.04" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.6"/>
                    <measurement group_id="O2" value="-1.7" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein</title>
        <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein</title>
          <description>Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="506"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="3.1"/>
                    <measurement group_id="O2" value="-1.6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="4.6"/>
                    <measurement group_id="O2" value="-1.5" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase</title>
        <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase</title>
          <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="452"/>
                <count group_id="O2" value="455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="17.0"/>
                    <measurement group_id="O2" value="-0.9" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate</title>
        <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate</title>
          <description>Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="506"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Direct bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="480"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.8"/>
                    <measurement group_id="O2" value="-0.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="493"/>
                    <count group_id="O2" value="503"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="3.6"/>
                    <measurement group_id="O2" value="-1.0" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="9.0"/>
                    <measurement group_id="O2" value="-3.5" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="506"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.8" spread="54.1"/>
                    <measurement group_id="O2" value="-17.9" spread="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate</title>
        <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.</description>
        <time_frame>End-of-stimulation visit and end-of-trial visit</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate</title>
          <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="494"/>
                <count group_id="O2" value="505"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine aminotransferase (IU/L) (End-of-stimulation)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="484"/>
                    <count group_id="O2" value="477"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase (IU/L) (End-of-stimulation)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="484"/>
                    <count group_id="O2" value="484"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate (mmol/L) (End-of-stimulation)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="489"/>
                    <count group_id="O2" value="501"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase (IU/L) (End-of-trial)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="488"/>
                    <count group_id="O2" value="480"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mmol/L) (End-of-trial)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="492"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mmol/L) (End-of-trial)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="494"/>
                    <count group_id="O2" value="505"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Erythrocytes</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Erythrocytes</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>10^12 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.31"/>
                    <measurement group_id="O2" value="-0.09" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameters: Leukocytes and Platelets</title>
        <description>Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameters: Leukocytes and Platelets</title>
          <description>Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="489"/>
                    <count group_id="O2" value="503"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.161" spread="2.232"/>
                    <measurement group_id="O2" value="0.996" spread="2.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="483"/>
                    <count group_id="O2" value="495"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="41.7"/>
                    <measurement group_id="O2" value="23.8" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Haemoglobin</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Haemoglobin</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="8.9"/>
                    <measurement group_id="O2" value="-1.7" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Haematocrit</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Haematocrit.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Haematocrit</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Haematocrit.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="480"/>
                <count group_id="O2" value="491"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.012" spread="0.033"/>
                    <measurement group_id="O2" value="-0.008" spread="0.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>Femtoliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="480"/>
                <count group_id="O2" value="491"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="3.3"/>
                    <measurement group_id="O2" value="0.1" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>picogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
                <count group_id="O2" value="503"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                    <measurement group_id="O2" value="0.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration</title>
        <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration</title>
          <description>Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="480"/>
                <count group_id="O2" value="491"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes</title>
        <description>Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes</title>
          <description>Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="489"/>
                <count group_id="O2" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.37"/>
                    <measurement group_id="O2" value="0.02" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="1.08"/>
                    <measurement group_id="O2" value="-0.07" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.05" spread="9.18"/>
                    <measurement group_id="O2" value="-1.39" spread="9.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.52"/>
                    <measurement group_id="O2" value="-0.04" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.20" spread="10.03"/>
                    <measurement group_id="O2" value="1.50" spread="9.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes</title>
        <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.</description>
        <time_frame>End-of-stimulation visit and end-of-trial visit</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes</title>
          <description>The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="474"/>
                <count group_id="O2" value="487"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytes (10^9 cells/L) (End-of-stimulation)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="455"/>
                    <count group_id="O2" value="460"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/leukocytes (%) (End-of-stimulation)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="471"/>
                    <count group_id="O2" value="481"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^9 cells/L) (End-of-trial)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="459"/>
                    <count group_id="O2" value="468"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/leukocytes (%) (End-of-trial)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="474"/>
                    <count group_id="O2" value="487"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Immune-related Adverse Events</title>
        <description>Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Immune-related Adverse Events</title>
          <description>Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Injection Site Reactions</title>
        <description>Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Injection Site Reactions</title>
          <description>Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2"/>
                    <measurement group_id="O2" value="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Injection Site Reactions</title>
        <description>Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Injection Site Reactions</title>
          <description>Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6"/>
                    <measurement group_id="O2" value="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity</title>
        <description>Measured by presence of anti-FSH antibodies.</description>
        <time_frame>Up to 28 days after end of the stimulation period</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity</title>
          <description>Measured by presence of anti-FSH antibodies.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-induced anti-FSH antibodies (Overall)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" lower_limit="0.57" upper_limit="2.87"/>
                    <measurement group_id="O2" value="0.98" lower_limit="0.32" upper_limit="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-induced anti-FSH antibodies with neutralizing capacity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">For participants with treatment-induced anti-FSH antibodies, none of the antibodies were of neutralizing capacity at any sampling time point.</measurement>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">For participants with treatment-induced anti-FSH antibodies, none of the antibodies were of neutralizing capacity at any sampling time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensity of Immune-related Adverse Events</title>
        <description>The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
        <time_frame>From screening up to end-of-trial (approximately 5.5 months)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Immune-related Adverse Events</title>
          <description>The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen</title>
        <description>For each participant the reason for cycle cancellation will be recorded.</description>
        <time_frame>Up to 20 stimulation days</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen</title>
          <description>For each participant the reason for cycle cancellation will be recorded.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse event (including immune-related adverse events)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Technical malfunctions of the administration pen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Late OHSS</title>
        <description>Late OHSS was defined as OHSS with onset &gt;9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.</description>
        <time_frame>After 9 days post triggering of final follicular maturation</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Late OHSS</title>
          <description>Late OHSS was defined as OHSS with onset &gt;9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Late OHSS (Any grade)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late OHSS (Moderate/severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Multi-fetal Gestation</title>
        <description>Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.</description>
        <time_frame>End-of-trial</time_frame>
        <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Multi-fetal Gestation</title>
          <description>Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.</description>
          <population>The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Early Pregnancy Losses</title>
        <description>Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).&#xD;
Frequency of early pregnancy losses are presented.</description>
        <time_frame>End-of-trial</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Early Pregnancy Losses</title>
          <description>Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).&#xD;
Frequency of early pregnancy losses are presented.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Technical Malfunctions of the Administration Pen</title>
        <description>Incidences of technical malfunctions of the administration pen were recorded.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 000049 (Follitropin Delta)</title>
            <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
          <group group_id="O2">
            <title>GONAL-F (Follitropin Alfa)</title>
            <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Technical Malfunctions of the Administration Pen</title>
          <description>Incidences of technical malfunctions of the administration pen were recorded.</description>
          <population>The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="499"/>
                <count group_id="O2" value="510"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were recorded from screening up to end-of-trial (up to approximately 5.5 months).</time_frame>
      <desc>Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit were considered treatment-emergent and are presented for the safety analysis set.&#xD;
The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>FE 000049 (Follitropin Delta)</title>
          <description>FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
        </group>
        <group group_id="E2">
          <title>GONAL-F (Follitropin Alfa)</title>
          <description>GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="499"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="499"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="499"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bartholin's abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="499"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="499"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Abortion threatened</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="499"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Biochemical pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="499"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Hyperemesis gravidarum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="499"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Vomiting in pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian hyperstimulation syndrome</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="499"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Adnexal torsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="499"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="97" subjects_at_risk="499"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Biochemical pregnancy</sub_title>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="499"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Haemorrhage in pregnancy</sub_title>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="499"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian hyperstimulation syndrome</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="499"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="510"/>
              </event>
              <event>
                <sub_title>Pelvic discomfort</sub_title>
                <counts group_id="E1" events="26" subjects_affected="25" subjects_at_risk="499"/>
                <counts group_id="E2" events="30" subjects_affected="28" subjects_at_risk="510"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Compliance</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <email>DK0-Disclosure@ferring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296527
org study id: 000145
nct id: NCT03296527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing
      pregnancy rate in women undergoing controlled ovarian stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Ongoing Pregnancy Rate
time frame: 10-11 weeks after transfer
description: Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.
measure: Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate
time frame: 13-15 days after transfer
description: Defined as positive βhCG test 13-15 days after transfer.
measure: Clinical Pregnancy Rate
time frame: 5-6 weeks after transfer
description: Defined as at least one gestational sac 5-6 weeks after transfer.
measure: Vital Pregnancy Rate
time frame: 5-6 weeks after transfer
description: Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.
measure: Implantation Rate
time frame: 5-6 weeks after transfer
description: Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.
measure: Ongoing Implantation Rate
time frame: 10-11 weeks after transfer
description: Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.
measure: Proportion of Subjects With Extreme Ovarian Responses
time frame: Oocyte retrieval visit
description: Extreme ovarian response defined as <4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as <4 oocytes retrieved.
measure: Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
time frame: Up to 9 days after triggering of final follicular maturation
description: Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
measure: Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk
time frame: End-of-stimulation visit (up to 20 days) or transfer visit
description: For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.
measure: Number of Follicles on Stimulation Day 6
time frame: On stimulation Day 6
description: Counted by ultrasound for the right and left ovary for each participant.
measure: Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)
time frame: At end-of-stimulation (up to 20 stimulation days)
description: Counted by ultrasound for the right and left ovary for each participant.
measure: Size of Follicles on Stimulation Day 6
time frame: On stimulation Day 6
description: Counted by ultrasound for the right and left ovary for each participant.
measure: Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)
time frame: At end-of-stimulation (up to 20 stimulation days)
description: Counted by ultrasound for the right and left ovary for each participant.
measure: Number of Oocytes Retrieved
time frame: On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)
description: The number of oocytes retrieved was recorded at the oocyte retrieval visit.
measure: Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
time frame: On the day of oocyte retrieval
description: Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the <4 oocytes group.
measure: Percentage of Metaphase II (MII) Oocytes
time frame: Prior to insemination
description: The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.
measure: Fertilization Rate
time frame: On Day 1 after oocyte retrieval
description: The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.
measure: Number and Quality of Embryos
time frame: On Day 3 after oocyte retrieval
description: Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.
measure: Circulating Concentrations of Luteinizing Hormone (LH)
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of LH
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.
measure: Circulating Concentrations of Estradiol
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of Estradiol
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.
measure: Circulating Concentrations of Progesterone
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of Progesterone
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.
measure: Circulating Concentrations of Inhibin A
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of Inhibin A
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.
measure: Circulating Concentrations of Inhibin B
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of Inhibin B
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.
measure: Circulating Concentrations of Follicle-stimulating Hormone (FSH)
time frame: On stimulation Day 6
description: Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.
measure: Circulating Concentrations of FSH
time frame: End-of-stimulation (up to 20 stimulation days)
description: Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.
measure: Circulating Concentrations of FSH
time frame: At oocyte retrieval
description: Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.
measure: Total Gonadotropin Dose
time frame: Up to 20 stimulation days
description: Calculated by start dates, end dates and daily dose of IMP.
measure: Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments
time frame: Up to 20 stimulation days
description: Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.
measure: Number of Stimulation Days
time frame: Up to 20 stimulation days
description: Calculated by start dates and end dates.
measure: Number of Participants With Adverse Events
time frame: From screening up to end-of-trial (up to approximately 5.5 months)
description: Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.
measure: Intensity of Adverse Events
time frame: From screening up to end-of-trial (up to approximately 5.5 months)
description: The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).
measure: Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase
time frame: From screening up to end-of-trial (up to approximately 5.5 months)
description: Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.
measure: Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.
measure: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.
measure: Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.
measure: Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.
measure: Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate
time frame: End-of-stimulation visit and end-of-trial visit
description: The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.
measure: Change From Baseline in Haematology Parameter: Erythrocytes
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.
measure: Change From Baseline in Haematology Parameters: Leukocytes and Platelets
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.
measure: Change From Baseline in Haematology Parameter: Haemoglobin
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.
measure: Change From Baseline in Haematology Parameter: Haematocrit
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Haematocrit.
measure: Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.
measure: Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.
measure: Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.
measure: Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.
measure: Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes
time frame: End-of-stimulation visit and end-of-trial visit
description: The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.
measure: Number of Immune-related Adverse Events
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).
measure: Frequency of Injection Site Reactions
time frame: End-of-stimulation (up to 20 stimulation days)
description: Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.
measure: Intensity of Injection Site Reactions
time frame: End-of-stimulation (up to 20 stimulation days)
description: Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.
measure: Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity
time frame: Up to 28 days after end of the stimulation period
description: Measured by presence of anti-FSH antibodies.
measure: Intensity of Immune-related Adverse Events
time frame: From screening up to end-of-trial (approximately 5.5 months)
description: The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).
measure: Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen
time frame: Up to 20 stimulation days
description: For each participant the reason for cycle cancellation will be recorded.
measure: Proportion of Subjects With Late OHSS
time frame: After 9 days post triggering of final follicular maturation
description: Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.
measure: Proportion of Participants With Multi-fetal Gestation
time frame: End-of-trial
description: Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.
measure: Proportion of Participants With Early Pregnancy Losses
time frame: End-of-trial
description: Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).
Frequency of early pregnancy losses are presented.
measure: Proportion of Participants With Technical Malfunctions of the Administration Pen
time frame: End-of-stimulation (up to 20 stimulation days)
description: Incidences of technical malfunctions of the administration pen were recorded.
arm group label: Follitropin delta
arm group type: Experimental
description: Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection
arm group label: Gonal-F
arm group type: Active Comparator
description: rFSH. Follitropin alfa for subcutaneous injection
intervention type: Drug
intervention name: Follitropin alfa
description: GONAL-F dose was fixed for the first 5 stimulation days.
arm group label: Gonal-F
other name: GONAL-F
intervention type: Drug
intervention name: Follitropin delta
description: REKOVELLE (FE 999049) was fixed throughout the stimulation period.
arm group label: Follitropin delta
other name: FE 999049
other name: REKOVELLE
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
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country: China
country: Korea, Republic of
country: Taiwan
country: Vietnam
citation: Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, Goethberg M, Mannaerts B, Arce JC. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Aug 18;36(9):2452-2462. doi: 10.1093/humrep/deab155.
PMID: 34179971
citation: Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, Yang Y, Tan J, Zhang Q, Sun Y, Wang W, Qian W, Jin L, Wang S, Xu Y, Yang J, Goethberg M, Mannaerts B, Wu W, Zheng Z, Qiao J. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022 Oct 4;20(1):147. doi: 10.1186/s12958-022-01016-y.
PMID: 36195924
citation: Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.
PMID: 37156263
responsible party type: Sponsor
mesh term: Follicle Stimulating Hormone
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