<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/NCT03228680</url>
  </required_header>
  <id_info>
    <org_study_id>000273</org_study_id>
    <nct_id>NCT03228680</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women</brief_title>
  <official_title>A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an 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 to FOLLISTIM with respect to number of&#xD;
      oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2017</start_date>
  <completion_date type="Actual">July 8, 2019</completion_date>
  <primary_completion_date type="Actual">June 10, 2019</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>Number of Oocytes Retrieved</measure>
    <time_frame>36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)</time_frame>
    <description>The number of oocytes retrieved was recorded at the oocyte retrieval visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>5-6 weeks after transfer (up to approximately 3 months after start of stimulation)</time_frame>
    <description>Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate</measure>
    <time_frame>13-15 days after transfer (up to approximately 1.5 months after start of stimulation)</time_frame>
    <description>Defined as positive serum beta-hCG test 13-15 days after transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Pregnancy Rate</measure>
    <time_frame>5-6 weeks after transfer (up to approximately 3 months after start of stimulation)</time_frame>
    <description>Vital pregnancy was 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 (up to approximately 3 months after start of stimulation)</time_frame>
    <description>Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</measure>
    <time_frame>On the day of oocyte retrieval (up to 22 days after start of stimulation)</time_frame>
    <description>Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with &lt;4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Extreme Ovarian Responses (Defined as &lt;4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population</measure>
    <time_frame>On the day of oocyte retrieval (up to 22 days after start of stimulation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)</measure>
    <time_frame>≤9 days after triggering of final follicular maturation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of Participants 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>Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)</measure>
    <time_frame>&gt;9 days after triggering of final follicular maturation</time_frame>
    <description>Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade).&#xD;
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>Number of Follicles on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Follicles at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of Follicles on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>Defined as size characteristics of follicles on stimulation Day 6.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of Follicles at End-of-Stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Defined as size characteristics of follicles at end-of-stimulation.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilization Rate</measure>
    <time_frame>Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)</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>Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)</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 fragmentation ≤20% on Day 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Quality of Blastocysts</measure>
    <time_frame>Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)</time_frame>
    <description>Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner &amp; Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The median and IQR of FSH and LH levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The median and IQR of estradiol levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The median and IQR of progesterone levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>The median and IQR of Inhibin A levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The median and IQR of Inhibin A levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6</measure>
    <time_frame>At Day 6 of stimulation</time_frame>
    <description>The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The median and IQR of inhibin B levels at end-of-stimulation are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Stimulation Days</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Gonadotropin Dose of FE 999049</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Gonadotropin Dose of FOLLISTIM</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) Stratified by Intensity</measure>
    <time_frame>From signed informed consent up to 5-6 weeks after transfer</time_frame>
    <description>The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE 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 Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial</measure>
    <time_frame>Up to 5-6 weeks after transfer</time_frame>
    <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial</measure>
    <time_frame>Up to 5-6 weeks after transfer</time_frame>
    <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and Intensity of Injection Site Reactions</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
    <description>The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Malfunctions of the Administration Pens</measure>
    <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">373</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Follitropin delta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Follitropin beta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin delta</intervention_name>
    <description>Single daily subcutaneous administration through pre-filled injection pen</description>
    <arm_group_label>Follitropin delta</arm_group_label>
    <other_name>FE 999049</other_name>
    <other_name>REKOVELLE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin beta</intervention_name>
    <description>Single daily subcutaneous injection in the abdomen</description>
    <arm_group_label>Follitropin beta</arm_group_label>
    <other_name>FOLLISTIM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Documents signed prior to any trial-related procedures.&#xD;
&#xD;
          -  In good physical and mental health.&#xD;
&#xD;
          -  Japanese females between the ages of 20 and 40 years.&#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) or with partners diagnosed with male factor&#xD;
             infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm&#xD;
             injection (ICSI) treatment using ejaculated sperm from male partner.&#xD;
&#xD;
          -  Infertility for at least 1 year before randomization (not applicable in case of tubal&#xD;
             or 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;
          -  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 screening. This also includes women who have been diagnosed with any of the&#xD;
             above medical conditions but have had them surgically corrected within 1 year prior to&#xD;
             screening.&#xD;
&#xD;
          -  Transvaginal ultrasound documenting presence and adequate visualization of both&#xD;
             ovaries, without evidence of significant abnormality (e.g. no endometrioma greater&#xD;
             than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and&#xD;
             fallopian tubes and surrounding tissue without evidence of significant abnormality&#xD;
             (e.g. no hydrosalpinx) within 1 year prior to screening. Both ovaries must be&#xD;
             accessible for oocyte retrieval.&#xD;
&#xD;
          -  Early follicular phase (cycle day 2-4) serum levels of follicle stimulating hormone&#xD;
             (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to screening).&#xD;
&#xD;
          -  Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known endometriosis stage III-IV (defined by the revised ASRM classification).&#xD;
&#xD;
          -  One or more follicles &gt;10 mm (including cysts) observed on the transvaginal ultrasound&#xD;
             prior to start of stimulation on stimulation day 1 (puncture of cysts prior&#xD;
             randomization is allowed).&#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. In case the sperm&#xD;
             production is severely impaired (concentration &lt;1 million/mL), normal karyotype,&#xD;
             including no Y chromosome microdeletion, must be documented.&#xD;
&#xD;
          -  Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of&#xD;
             these events.&#xD;
&#xD;
          -  Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).&#xD;
&#xD;
          -  Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or&#xD;
             kidney) which can compromise participation in the trial with the exception of&#xD;
             controlled thyroid function disease.&#xD;
&#xD;
          -  Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus&#xD;
             which would contraindicate the use of gonadotropins.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <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>Yachiyo Hospital</name>
      <address>
        <city>Anjo</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8121</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokota Maternity Hospital</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sophia Ladies Clinic</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8122</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8123</name>
      <address>
        <city>Higashiōsaka-shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8120</name>
      <address>
        <city>Osaka-Shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ladies Clinic Kitahama</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8125</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8124</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamashita Ladies' Clinic</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 8126</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omiya Ladies Clinic</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Women's Clinic</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Clinic Fujimino</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Ishihara O, Arce JC; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-918. doi: 10.1016/j.rbmo.2021.01.023. Epub 2021 Feb 9.</citation>
    <PMID>33722477</PMID>
  </results_reference>
  <results_reference>
    <citation>Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.</citation>
    <PMID>34799275</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>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <results_first_submitted>January 20, 2021</results_first_submitted>
  <results_first_submitted_qc>March 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</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>March 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03228680/Prot_000.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>August 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03228680/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 17 investigational sites in Japan randomized participants to the trial between 29 July 2017 to 08 July 2019.</recruitment_details>
      <pre_assignment_details>A total of 373 participants were screened. Of these, 25 were screening failures and 348 participants were randomized: 170 participants were exposed to FE 999049 &amp; 177 participants were exposed to FOLLISTIM. One participant was randomized to FOLLISTIM but not exposed to investigational medicinal product (IMP) was considered a randomization failure.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
          <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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="170"/>
                <participants group_id="P2" count="178"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomization failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
          <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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="170"/>
            <count group_id="B2" value="177"/>
            <count group_id="B3" value="347"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Number analyzed differs from the overall population as one participant in the FOLLISTIM (Follitropin beta) group was randomized but not exposed to treatment.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.2" spread="3.5"/>
                    <measurement group_id="B2" value="34.0" spread="3.4"/>
                    <measurement group_id="B3" value="34.1" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Number analyzed differs from the overall population as one participant in the FOLLISTIM (Follitropin beta) group was randomized but not exposed to treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="347"/>
                  </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>
          <description>Number analyzed differs from the overall population as one participant in the FOLLISTIM (Follitropin beta) group was randomized but not exposed to treatment.</description>
          <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="170"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="347"/>
                  </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 (NIH/OMB)</title>
          <description>Number analyzed differs from the overall population as one participant in the FOLLISTIM (Follitropin beta) group was randomized but not exposed to treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="347"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</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>White</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>More than one race</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>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>Region of Enrollment</title>
          <description>Number analyzed differs from the overall population as one participant in the FOLLISTIM (Follitropin beta) group was randomized but not exposed to treatment.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Oocytes Retrieved</title>
        <description>The number of oocytes retrieved was recorded at the oocyte retrieval visit.</description>
        <time_frame>36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)</time_frame>
        <population>The full analysis set (FAS) comprised all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 full analysis set (FAS) comprised all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="5.4"/>
                    <measurement group_id="O2" value="10.5" spread="6.1"/>
                  </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>Mean number of oocytes retrieved.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
            <estimate_desc>If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Pregnancy Rate</title>
        <description>Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.</description>
        <time_frame>5-6 weeks after transfer (up to approximately 3 months after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3"/>
                    <measurement group_id="O2" value="23.7"/>
                  </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 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>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.5</ci_lower_limit>
            <ci_upper_limit>10.6</ci_upper_limit>
            <estimate_desc>The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate</title>
        <description>Defined as positive serum beta-hCG test 13-15 days after transfer.</description>
        <time_frame>13-15 days after transfer (up to approximately 1.5 months after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 (Beta-hCG) Rate</title>
          <description>Defined as positive serum beta-hCG test 13-15 days after transfer.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                    <measurement group_id="O2" value="29.4"/>
                  </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>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>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.5</ci_lower_limit>
            <ci_upper_limit>9.6</ci_upper_limit>
            <estimate_desc>The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vital Pregnancy Rate</title>
        <description>Vital pregnancy was 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 (up to approximately 3 months after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5"/>
                    <measurement group_id="O2" value="21.5"/>
                  </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>Percentage of participants with vital pregnancy.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.7</ci_lower_limit>
            <ci_upper_limit>10.8</ci_upper_limit>
            <estimate_desc>The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implantation Rate</title>
        <description>Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.</description>
        <time_frame>5-6 weeks after transfer (up to approximately 3 months after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants with blastocyst transfer.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.</description>
          <population>The FAS comprised of all randomized and exposed participants with blastocyst transfer.</population>
          <units>% of sacs/blastocysts 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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Embryos transferred</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9"/>
                    <measurement group_id="O2" value="29.8"/>
                  </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 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>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.9</ci_lower_limit>
            <ci_upper_limit>12.8</ci_upper_limit>
            <estimate_desc>The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Cycle Cancellation Due to Poor or Excessive Ovarian Response</title>
          <population>The FAS comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle cancelled due to poor ovarian response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle cancelled due to excessive ovarian response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk</title>
          <population>The FAS comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="11.3"/>
                  </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>Proportion of participants with blastocyst transfer cancellation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.244</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</title>
        <description>Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with &lt;4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.</description>
        <time_frame>On the day of oocyte retrieval (up to 22 days after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 &lt;4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved</title>
          <description>Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with &lt;4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Low response (&lt;4 oocytes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate response (4-7 oocytes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1"/>
                    <measurement group_id="O2" value="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Targeted response (8-14 oocytes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                    <measurement group_id="O2" value="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperresponse (15-19 oocytes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hyperresponse (≥ 20 oocytes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                    <measurement group_id="O2" value="11.0"/>
                  </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>Proportion of participants with &lt;4 oocytes retrieved (low response).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.254</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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 4-7 oocytes retrieved (moderate response).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.041</p_value>
            <p_value_desc>P-value was based on likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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 8-14 oocytes retrieved (targeted response).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.705</p_value>
            <p_value_desc>P-value was based on likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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 15-19 oocytes retrieved (hyperresponse).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.183</p_value>
            <p_value_desc>P-value was based on likelihood ratio test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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 &gt;= (more than equal to) 20 oocytes retrieved (severe hyperresponse).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.030</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Extreme Ovarian Responses (Defined as &lt;4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population</title>
        <time_frame>On the day of oocyte retrieval (up to 22 days after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Extreme Ovarian Responses (Defined as &lt;4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population</title>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AMH &lt; 15 pmol/L (&lt;4 oocytes retrieved)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                    <measurement group_id="O2" value="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AMH &gt;= 15 pmol/L (&gt;=15 oocytes retrieved)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0"/>
                    <measurement group_id="O2" value="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AMH &gt;= 15 pmol/L (&gt;=20 oocytes retrieved)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="19.0"/>
                  </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>Proportion of participants with extreme ovarian responses: AMH &lt; 15 pmol/L (&lt;4 oocytes retrieved)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.893</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with extreme ovarian responses: AMH &gt;= 15 pmol/L (&gt;=15 oocytes retrieved)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportion of participants with extreme ovarian responses: AMH &gt;= 15 pmol/L (&gt;=20 oocytes retrieved)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.021</p_value>
            <p_value_desc>P-value based on likelihood ratio chi-square test.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)</title>
        <time_frame>≤9 days after triggering of final follicular maturation</time_frame>
        <population>The FAS comprised of all participants randomized or exposed.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)</title>
          <population>The FAS comprised of all participants randomized or exposed.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle cancellation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triggering with GnRH agonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administration of dopamine agonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS</title>
        <description>Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.</description>
        <time_frame>Up to 9 days after triggering of final follicular maturation</time_frame>
        <population>The FAS comprised of all participants randomized and exposed.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS</title>
          <description>Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.</description>
          <population>The FAS comprised of all participants randomized and exposed.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Early OHSS (any grade)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                    <measurement group_id="O2" value="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (moderate/severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (any grade) and/or preventive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                    <measurement group_id="O2" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Early OHSS (moderate/severe) and/or preventive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="16.4"/>
                  </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>Proportions of participants with early OHSS (any grade).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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>Superiority</non_inferiority_type>
            <p_value>0.035</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_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>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)</title>
        <description>Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade).&#xD;
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>&gt;9 days after triggering of final follicular maturation</time_frame>
        <population>The FAS comprised of all participants randomized or exposed.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)</title>
          <description>Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade).&#xD;
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 FAS comprised of all participants randomized or exposed.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Late OHSS (any grade)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Late OHSS (moderate/severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="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>Proportions of participants with late OHSS (any grade).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.968</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Proportions of participants with late OHSS (moderate/severe).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.582</p_value>
            <p_value_desc>P-value was based on likelihood ratio chi-square test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>The model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Follicles on Stimulation Day 6</title>
        <description>Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized or exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).</description>
          <population>The FAS comprised of all randomized or exposed participants.</population>
          <units>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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="7.2"/>
                    <measurement group_id="O2" value="13.3" spread="7.1"/>
                  </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>The number of follicles on stimulation Day 6 was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.198</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Follicles at End-of-stimulation</title>
        <description>Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS comprised of all randomized or exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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</title>
          <description>Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).</description>
          <population>The FAS comprised of all randomized or exposed participants.</population>
          <units>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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="8.0"/>
                    <measurement group_id="O2" value="16.3" spread="8.8"/>
                  </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>The number of follicles at end-of-stimulation was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.036</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Size of Follicles on Stimulation Day 6</title>
        <description>Defined as size characteristics of follicles on stimulation Day 6.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Defined as size characteristics of follicles on stimulation Day 6.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
          <population>The FAS comprised of all randomized and exposed participants</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="2.1"/>
                    <measurement group_id="O2" value="12.8" 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>The average size of 3 largest follicles was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.592</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Size of Follicles at End-of-Stimulation</title>
        <description>Defined as size characteristics of follicles at end-of-stimulation.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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</title>
          <description>Defined as size characteristics of follicles at end-of-stimulation.&#xD;
Average size of 3 largest follicles has been presented in this endpoint.</description>
          <population>The FAS comprised of all randomized and exposed participants</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="1.5"/>
                    <measurement group_id="O2" value="19.4" 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>The average size of 3 largest follicles was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.286</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</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>Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)</time_frame>
        <population>The FAS comprised all randomized and exposed participants</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>The FAS comprised all randomized and exposed participants</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5" spread="26.1"/>
                    <measurement group_id="O2" value="57.1" spread="23.4"/>
                  </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>The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.395</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</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 fragmentation ≤20% on Day 3.</description>
        <time_frame>Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 fragmentation ≤20% on Day 3.</description>
          <population>The FAS comprised of all randomized and exposed participants.</population>
          <units>Embryo</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of embryo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="4.2"/>
                    <measurement group_id="O2" value="7.0" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of good-quality embryo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="3.3"/>
                    <measurement group_id="O2" value="4.6" spread="3.3"/>
                  </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>The number of embryos on Day 3 was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The number of good-quality embryos on Day 3 was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Quality of Blastocysts</title>
        <description>Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner &amp; Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.</description>
        <time_frame>Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Blastocysts</title>
          <description>Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner &amp; Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.</description>
          <population>The FAS comprised of all randomized and exposed participants.</population>
          <units>Blastocysts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of blastocysts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.7"/>
                    <measurement group_id="O2" value="4.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of good-quality blastocysts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.3"/>
                    <measurement group_id="O2" value="3.0" spread="2.6"/>
                  </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>The number of blastocysts on Day 5 was analyzed.</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 was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The number of good-quality blastocysts on Day 5 was analyzed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6</title>
        <description>The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6</title>
          <description>The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="166"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FSH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="12.0" upper_limit="19.6"/>
                    <measurement group_id="O2" value="14.7" lower_limit="12.8" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.5" upper_limit="6.2"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.6" upper_limit="5.9"/>
                  </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 levels of FSH on stimulation Day 6.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.228</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</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>0.98</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating levels of LH on stimulation Day 6.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.777</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation</title>
        <description>The median and IQR of FSH and LH levels at end-of-stimulation are presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation</title>
          <description>The median and IQR of FSH and LH levels at end-of-stimulation are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FSH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="11.6" upper_limit="19.7"/>
                    <measurement group_id="O2" value="16.4" lower_limit="13.5" upper_limit="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.0" upper_limit="2.5"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.9" upper_limit="2.3"/>
                  </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 levels 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 the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</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>0.84</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Circulating levels of LH at end-of-stimulation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.057</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6</title>
        <description>The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6</title>
          <description>The median and IQR of estradiol levels on stimulation Day 6 are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="166"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2277.1" lower_limit="1479.4" upper_limit="3580.1"/>
                    <measurement group_id="O2" value="2680.0" lower_limit="1608.8" upper_limit="4685.9"/>
                  </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 levels of estradiol on stimulation Day 6.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</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>0.71</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation</title>
        <description>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 comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameter (Estradiol) at End-of-stimulation</title>
          <description>The median and IQR of estradiol levels at end-of-stimulation are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6517.0" lower_limit="4465.3" upper_limit="9033.4"/>
                    <measurement group_id="O2" value="7438.8" lower_limit="5363.6" upper_limit="10283.1"/>
                  </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 levels of estradiol at end-of-stimulation.</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6</title>
        <description>The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6</title>
          <description>The median and IQR of progesterone levels on stimulation Day 6 are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="166"/>
                <count group_id="O2" value="175"/>
              </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="2.4"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.8" upper_limit="2.65"/>
                  </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 levels of progesterone on stimulation Day 6.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.814</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>1.02</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>1.16</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation</title>
        <description>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 comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameter (Progesterone) at End-of-stimulation</title>
          <description>The median and IQR of progesterone levels at end-of-stimulation are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="168"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.9" upper_limit="3.5"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.3" upper_limit="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>Circulating levels of progesterone levels 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 the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.78</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>0.88</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6</title>
        <description>The median and IQR of Inhibin A levels on stimulation Day 6 are presented.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6</title>
          <description>The median and IQR of Inhibin A levels on stimulation Day 6 are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="166"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.1" lower_limit="75.1" upper_limit="171.9"/>
                    <measurement group_id="O2" value="129.8" lower_limit="81.6" upper_limit="210.6"/>
                  </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 levels 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 the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation</title>
        <description>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 comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation</title>
          <description>The median and IQR of Inhibin A levels at end-of-stimulation are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323.8" lower_limit="222.1" upper_limit="458.8"/>
                    <measurement group_id="O2" value="390.3" lower_limit="301.0" upper_limit="551.1"/>
                  </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 levels 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 the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6</title>
        <description>The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
        <time_frame>At Day 6 of stimulation</time_frame>
        <population>The FAS comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6</title>
          <description>The median and IQR of inhibin B levels on stimulation Day 6 are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="166"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570.5" lower_limit="396.0" upper_limit="853.0"/>
                    <measurement group_id="O2" value="686.0" lower_limit="431.0" upper_limit="1004.0"/>
                  </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 levels 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 the two-sided F-test of treatment effect.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>The ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</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>0.75</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation</title>
        <description>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 comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation</title>
          <description>The median and IQR of inhibin B levels at end-of-stimulation are presented.</description>
          <population>The FAS comprised of all randomized and exposed participants.</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="169"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="686.0" lower_limit="461.0" upper_limit="1057.0"/>
                    <measurement group_id="O2" value="734.5" lower_limit="492.5" upper_limit="1120.5"/>
                  </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 levels of Inhibin B at end-of-stimulation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.027</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 ANCOVA model included treatment and AMH stratum (&lt;15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.</method_desc>
            <param_type>Mean ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
            <estimate_desc>Mean ratio is equal to FE 999049/FOLLISTIM.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Stimulation Days</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>
          <population>The safety analysis set comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="1.9"/>
                    <measurement group_id="O2" value="8.8" spread="1.7"/>
                  </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>The number of stimulation days at end-of-stimulation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.694</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>van Elteren test</method>
            <method_desc>P-value was based on van Elteren test adjusted for AMH strata.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Gonadotropin Dose of FE 999049</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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 of FE 999049</title>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>μg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Gonadotropin Dose of FOLLISTIM</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 of FOLLISTIM</title>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>IU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1499" spread="514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) Stratified by Intensity</title>
        <description>The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE 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 signed informed consent up to 5-6 weeks after transfer</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 (AEs) Stratified by Intensity</title>
          <description>The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE 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 comprised of all randomized and exposed participants.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation</title>
        <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation</title>
          <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT (IU/L): Normal to markedly high (&gt;3xULN)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST (IU/L): Normal to markedly high (&gt;3xULN)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation</title>
        <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation</title>
          <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </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>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial</title>
        <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
        <time_frame>Up to 5-6 weeks after transfer</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial</title>
          <description>Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.</description>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </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>Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial</title>
        <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
        <time_frame>Up to 5-6 weeks after transfer</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial</title>
          <description>Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.</description>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Leukocytes (10^9/L) Normal to markedly high (&gt;=16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin (g/L) Normal to markedly low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (ratio) Normal to markedly low (&gt;=0.56)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency and Intensity of Injection Site Reactions</title>
        <description>The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.</description>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 and Intensity of Injection Site Reactions</title>
          <description>The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.</description>
          <population>The safety analysis set comprised of all randomized and exposed participants.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any mild injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="271"/>
                    <measurement group_id="O2" value="719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any moderate injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any severe injection site reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe redness</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>Mild itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe itching</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>Mild pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe pain</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>Mild swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate swelling</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 swelling</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>Mild bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Malfunctions of the Administration Pens</title>
        <time_frame>End-of-stimulation (up to 20 stimulation days)</time_frame>
        <population>The safety analysis set comprised of all randomized and exposed participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
            <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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>Technical Malfunctions of the Administration Pens</title>
          <population>The safety analysis set comprised of all randomized and exposed participants.</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="170"/>
                <count group_id="O2" value="177"/>
              </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_list>

    <reported_events>
      <time_frame>Adverse events were monitored from the time of obtaining informed consent until the last visit (end-of-trial) (up to approximately 2 years) .</time_frame>
      <desc>Adverse events with onset after start of first administration of IMP were considered treatment -emergent and are presented for the safety analysis set.</desc>
      <group_list>
        <group group_id="E1">
          <title>FE 999049 (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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. 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>FOLLISTIM (Follitropin Beta)</title>
          <description>FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 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 (20.0)</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="170"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="177"/>
              </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="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (20.0)</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="73" subjects_at_risk="170"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="170"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="177"/>
              </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="6" subjects_affected="6" subjects_at_risk="170"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Abortion spontenous</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Haemorrhage in pregnancy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </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="19" subjects_affected="19" subjects_at_risk="170"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Ovarian enlargement</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="170"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Pelvic fluid collection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="177"/>
              </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>Clinical Development Support</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/NCT03228680
org study id: 000273
nct id: NCT03228680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of
      oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Number of Oocytes Retrieved
time frame: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)
description: The number of oocytes retrieved was recorded at the oocyte retrieval visit.
measure: Clinical Pregnancy Rate
time frame: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
description: Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
measure: Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate
time frame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
description: Defined as positive serum beta-hCG test 13-15 days after transfer.
measure: Vital Pregnancy Rate
time frame: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
description: Vital pregnancy was 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 (up to approximately 3 months after start of stimulation)
description: Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.
measure: Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response
time frame: End-of-stimulation (up to 20 stimulation days)
measure: Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk
time frame: End-of-stimulation (up to 20 stimulation days)
measure: Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
time frame: On the day of oocyte retrieval (up to 22 days after start of stimulation)
description: Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with <4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.
measure: Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
time frame: On the day of oocyte retrieval (up to 22 days after start of stimulation)
measure: Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
time frame: ≤9 days after triggering of final follicular maturation
measure: Proportions of Participants 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: Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.
measure: Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)
time frame: >9 days after triggering of final follicular maturation
description: Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade).
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: Number of Follicles on Stimulation Day 6
time frame: At Day 6 of stimulation
description: Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).
measure: Number of Follicles at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).
measure: Size of Follicles on Stimulation Day 6
time frame: At Day 6 of stimulation
description: Defined as size characteristics of follicles on stimulation Day 6.
Average size of 3 largest follicles has been presented in this endpoint.
measure: Size of Follicles at End-of-Stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: Defined as size characteristics of follicles at end-of-stimulation.
Average size of 3 largest follicles has been presented in this endpoint.
measure: Fertilization Rate
time frame: Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)
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: Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)
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 fragmentation ≤20% on Day 3.
measure: Number and Quality of Blastocysts
time frame: Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)
description: Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner & Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
measure: Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6
time frame: At Day 6 of stimulation
description: The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.
measure: Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: The median and IQR of FSH and LH levels at end-of-stimulation are presented.
measure: Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6
time frame: At Day 6 of stimulation
description: The median and IQR of estradiol levels on stimulation Day 6 are presented.
measure: Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: The median and IQR of estradiol levels at end-of-stimulation are presented.
measure: Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6
time frame: At Day 6 of stimulation
description: The median and IQR of progesterone levels on stimulation Day 6 are presented.
measure: Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: The median and IQR of progesterone levels at end-of-stimulation are presented.
measure: Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6
time frame: At Day 6 of stimulation
description: The median and IQR of Inhibin A levels on stimulation Day 6 are presented.
measure: Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: The median and IQR of Inhibin A levels at end-of-stimulation are presented.
measure: Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6
time frame: At Day 6 of stimulation
description: The median and IQR of inhibin B levels on stimulation Day 6 are presented.
measure: Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: The median and IQR of inhibin B levels at end-of-stimulation are presented.
measure: Number of Stimulation Days
time frame: End-of-stimulation (up to 20 stimulation days)
measure: Total Gonadotropin Dose of FE 999049
time frame: End-of-stimulation (up to 20 stimulation days)
measure: Total Gonadotropin Dose of FOLLISTIM
time frame: End-of-stimulation (up to 20 stimulation days)
measure: Number of Participants With Adverse Events (AEs) Stratified by Intensity
time frame: From signed informed consent up to 5-6 weeks after transfer
description: The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of AE 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 Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
measure: Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation
time frame: End-of-stimulation (up to 20 stimulation days)
description: Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
measure: Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial
time frame: Up to 5-6 weeks after transfer
description: Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
measure: Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
time frame: Up to 5-6 weeks after transfer
description: Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
measure: Frequency and Intensity of Injection Site Reactions
time frame: End-of-stimulation (up to 20 stimulation days)
description: The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.
measure: Technical Malfunctions of the Administration Pens
time frame: End-of-stimulation (up to 20 stimulation days)
arm group label: Follitropin delta
arm group type: Experimental
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. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
arm group label: Follitropin beta
arm group type: Active Comparator
description: FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM 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 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
intervention type: Drug
intervention name: Follitropin delta
description: Single daily subcutaneous administration through pre-filled injection pen
arm group label: Follitropin delta
other name: FE 999049
other name: REKOVELLE
intervention type: Drug
intervention name: Follitropin beta
description: Single daily subcutaneous injection in the abdomen
arm group label: Follitropin beta
other name: FOLLISTIM
criteria: 
gender: Female
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: Japan
citation: Ishihara O, Arce JC; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-918. doi: 10.1016/j.rbmo.2021.01.023. Epub 2021 Feb 9.
PMID: 33722477
citation: Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
PMID: 34799275
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: Infertility
mesh term: Follicle Stimulating Hormone
sharing ipd: No
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