<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/NCT04416607</url>
  </required_header>
  <id_info>
    <org_study_id>87020518800005327</org_study_id>
    <nct_id>NCT04416607</nct_id>
  </id_info>
  <brief_title>Corifollitropin Alpha and Ovarian Response</brief_title>
  <official_title>Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Objective: To study whether an administration of corifollitropin alpha modifies the&#xD;
      follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal&#xD;
      gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).&#xD;
&#xD;
      M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation&#xD;
      protocol will be performed with a single dose of 100 μg (&lt;60kg) or 150 μg (≥60kg)&#xD;
      corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin&#xD;
      (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in&#xD;
      group 2 (n=150).&#xD;
&#xD;
      Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in&#xD;
      diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be allocated for convenience into two groups: those who would receive&#xD;
      corifollitropin alpha (Group 1) or HMG (Group 2).&#xD;
&#xD;
      Ovarian stimulation protocol will be performed with a single dose of 100 μg (&lt;60 kg) or 150&#xD;
      μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1, which&#xD;
      could be followed by daily administration of HMG beginning on day 8 if necessary; in group 2&#xD;
      150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) will be administered, starting on&#xD;
      cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone&#xD;
      antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a&#xD;
      flexible protocol (at least 1 follicle &gt;14 mm or 3 or more follicles &gt;12 mm). Doses will be&#xD;
      adjusted as needed by the patient according to the ultrasound, which is performed with a 6&#xD;
      MHz multifrequency transvaginal probe (Toshiba, Japan). The criterion for HCG administration&#xD;
      (5.000 IU Choriomon, Biopharma, Brazil) will be at least three follicles greater than 17 mm,&#xD;
      and then, 36 hours later, transvaginal oocyte retrieval was performed. After 3 or 5 days, one&#xD;
      or two good-quality embryos will be transferred. It will be performed intracytoplasmic sperm&#xD;
      injection (ICSI) instead of conventional IVF when major male factor is presented.&#xD;
&#xD;
      Primary outcome measure is FORT. Secondary outcome measures include number of oocytes&#xD;
      retrieved, MII, duration of stimulation, number of embryos, embryo quality and clinical&#xD;
      pregnancy rate. Adverse events, such as ovarian hyperstimulation syndrome (OHSS) or&#xD;
      drug-related complications are also monitored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FORT</measure>
    <time_frame>15 days</time_frame>
    <description>FORT is calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG × 100/small antral follicle (3 -8 mm in diameter) count at baseline</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>corifollitropin alpha</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ovarian stimulation protocol is performed with a single dose of 100 μg (&lt;60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil), plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle &gt;14 mm or 3 or more follicles &gt;12 mm).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>menotropin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) is administered, starting on cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle &gt;14 mm or 3 or more follicles &gt;12 mm).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin Alfa</intervention_name>
    <description>Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.</description>
    <arm_group_label>corifollitropin alpha</arm_group_label>
    <other_name>Elonva® (Schering-Plough)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Menotropins</intervention_name>
    <description>Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.</description>
    <arm_group_label>menotropin</arm_group_label>
    <other_name>Menopur® (Ferring)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regular menstrual cycles;&#xD;
&#xD;
          -  Body mass index (BMI) of &lt;33.0 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ovarian surgery;&#xD;
&#xD;
          -  Current diagnosis of polycystic ovarian syndrome (PCOS) or other endocrinopathies;&#xD;
&#xD;
          -  History of autoimmune or metabolic disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joao Sabino Lahorgue da Cunha Filho, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Reproduçao Humana Insemine</name>
      <address>
        <city>Porto Alegre</city>
        <state>RGS</state>
        <zip>90001003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RGS</state>
        <zip>90003051</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menotropins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04416607
org study id: 87020518800005327
nct id: NCT04416607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To study whether an administration of corifollitropin alpha modifies the
      follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal
      gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

      M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation
      protocol will be performed with a single dose of 100 μg (<60kg) or 150 μg (≥60kg)
      corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin
      (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in
      group 2 (n=150).

      Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in
      diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.
Patients will be allocated for convenience into two groups: those who would receive
      corifollitropin alpha (Group 1) or HMG (Group 2).

      Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60 kg) or 150
      μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1, which
      could be followed by daily administration of HMG beginning on day 8 if necessary; in group 2
      150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) will be administered, starting on
      cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone
      antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a
      flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm). Doses will be
      adjusted as needed by the patient according to the ultrasound, which is performed with a 6
      MHz multifrequency transvaginal probe (Toshiba, Japan). The criterion for HCG administration
      (5.000 IU Choriomon, Biopharma, Brazil) will be at least three follicles greater than 17 mm,
      and then, 36 hours later, transvaginal oocyte retrieval was performed. After 3 or 5 days, one
      or two good-quality embryos will be transferred. It will be performed intracytoplasmic sperm
      injection (ICSI) instead of conventional IVF when major male factor is presented.

      Primary outcome measure is FORT. Secondary outcome measures include number of oocytes
      retrieved, MII, duration of stimulation, number of embryos, embryo quality and clinical
      pregnancy rate. Adverse events, such as ovarian hyperstimulation syndrome (OHSS) or
      drug-related complications are also monitored.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: FORT
time frame: 15 days
description: FORT is calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG × 100/small antral follicle (3 -8 mm in diameter) count at baseline
arm group label: corifollitropin alpha
arm group type: Experimental
description: Ovarian stimulation protocol is performed with a single dose of 100 μg (<60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil), plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm).
arm group label: menotropin
arm group type: Active Comparator
description: 150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) is administered, starting on cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm).
intervention type: Drug
intervention name: Corifollitropin Alfa
description: Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
arm group label: corifollitropin alpha
other name: Elonva® (Schering-Plough)
intervention type: Drug
intervention name: Menotropins
description: Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
arm group label: menotropin
other name: Menopur® (Ferring)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Joao Sabino Lahorgue da Cunha Filho, Ph.D.
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Menotropins
sharing ipd: No