<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/NCT01669291</url>
  </required_header>
  <id_info>
    <org_study_id>MLFC-003</org_study_id>
    <nct_id>NCT01669291</nct_id>
  </id_info>
  <brief_title>Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation</brief_title>
  <official_title>Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Main Line Fertility Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Main Line Fertility Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long&#xD;
      protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for&#xD;
      assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No detailed description&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine if COH in IVF patients using Bravelle &amp; Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determined if COH in IVF patients using Bravelle &amp; Menopur with antagonists results in lower peak estradiol levels compared to agonist</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if COH patients using Bravelle &amp; Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Fertility</condition>
  <arm_group>
    <arm_group_label>Bravelle &amp; Menopur Agonist Long Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bravelle &amp; Menopur Antagonist Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bravelle and Menopur</intervention_name>
    <description>Bravelle and Menopur are used for controlled ovarian stimulation (COH)</description>
    <arm_group_label>Bravelle &amp; Menopur Agonist Long Protocol</arm_group_label>
    <arm_group_label>Bravelle &amp; Menopur Antagonist Protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Agonist</intervention_name>
    <description>Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.</description>
    <arm_group_label>Bravelle &amp; Menopur Agonist Long Protocol</arm_group_label>
    <other_name>Leuprolide Acetate</other_name>
    <other_name>Lupron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antagonist</intervention_name>
    <description>Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.</description>
    <arm_group_label>Bravelle &amp; Menopur Antagonist Protocol</arm_group_label>
    <other_name>ganirelix acetate</other_name>
    <other_name>cetrorelix acetate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 21-40 (inclusive up to 41)&#xD;
&#xD;
          -  Day 2-4 FSH &lt; or equal to 10&#xD;
&#xD;
          -  Antimullerian Hormone (AMH) greater than or equal to 1.0&#xD;
&#xD;
          -  Between 5 and 20 antral follicles on day 2-4&#xD;
&#xD;
          -  Body Mass Index (BMI)&gt;or equal to 18 and &lt; or equal to 32&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Polycystic Ovarian Disease&#xD;
&#xD;
          -  Endometriosis greater than Stage I&#xD;
&#xD;
          -  Testicular aspirated sperm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Glassner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Main Line Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharon H. Anderson, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Main Line Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Main Line Fertility Center</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.</citation>
  </reference>
  <reference>
    <citation>Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2.</citation>
    <PMID>11789740</PMID>
  </reference>
  <reference>
    <citation>Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.</citation>
    <PMID>11163814</PMID>
  </reference>
  <reference>
    <citation>Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479.</citation>
    <PMID>10985616</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>June 3, 2014</last_update_submitted>
  <last_update_submitted_qc>June 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Cetrorelix</mesh_term>
    <mesh_term>Menotropins</mesh_term>
    <mesh_term>Ganirelix</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01669291
org study id: MLFC-003
nct id: NCT01669291
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long
      protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for
      assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
No detailed description
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.
time frame: One year
measure: To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist
time frame: One year
measure: To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.
time frame: One year
arm group label: Bravelle & Menopur Agonist Long Protocol
arm group type: Active Comparator
description: Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.
arm group label: Bravelle & Menopur Antagonist Protocol
arm group type: Active Comparator
description: Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.
intervention type: Drug
intervention name: Bravelle and Menopur
description: Bravelle and Menopur are used for controlled ovarian stimulation (COH)
arm group label: Bravelle & Menopur Agonist Long Protocol
arm group label: Bravelle & Menopur Antagonist Protocol
intervention type: Drug
intervention name: Agonist
description: Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
arm group label: Bravelle & Menopur Agonist Long Protocol
other name: Leuprolide Acetate
other name: Lupron
intervention type: Drug
intervention name: Antagonist
description: Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
arm group label: Bravelle & Menopur Antagonist Protocol
other name: ganirelix acetate
other name: cetrorelix acetate
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Glassner, M.D.
role: Principal Investigator
affiliation: Main Line Fertility Center
last name: Sharon H. Anderson, Ph.D
role: Study Director
affiliation: Main Line Fertility Center
facility: 
country: United States
citation: Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.
citation: Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2.
PMID: 11789740
citation: Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
PMID: 11163814
citation: Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479.
PMID: 10985616
responsible party type: Sponsor
mesh term: Leuprolide
mesh term: Cetrorelix
mesh term: Menotropins
mesh term: Ganirelix