<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/NCT01732068</url>
  </required_header>
  <id_info>
    <org_study_id>2012/082</org_study_id>
    <nct_id>NCT01732068</nct_id>
  </id_info>
  <brief_title>Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol</brief_title>
  <official_title>Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to examine the level of ovarian response and the&#xD;
      pregnancy rates among poor ovarian responders treated with a novel treatment protocol with&#xD;
      150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after&#xD;
      injection , a time interval which is significantly shorter as compared to treatment with&#xD;
      rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration&#xD;
      may result in a significantly higher exposure of the small antral follicles to constant high&#xD;
      levels of FSH during the early follicular phase, securing not only the recruitment of the&#xD;
      follicles, but also the continued growth.&#xD;
&#xD;
      In the current study the investigators examine whether administration of corifollitropin&#xD;
      followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy&#xD;
      rates in poor ovarian responders fulfilling the &quot;Bologna criteria&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>10 to 12 weeks of gestation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes retrieved</measure>
    <time_frame>Day of oocyte retrieval</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cycles with embryo transfer</measure>
    <time_frame>Day of Embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Infertility</condition>
  <condition>Poor Ovarian Response</condition>
  <arm_group>
    <arm_group_label>Corifollitropin alfa+hMG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin</intervention_name>
    <description>Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards</description>
    <arm_group_label>Corifollitropin alfa+hMG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin alfa</intervention_name>
    <description>Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle</description>
    <arm_group_label>Corifollitropin alfa+hMG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hpHMG</intervention_name>
    <description>300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering</description>
    <arm_group_label>Corifollitropin alfa+hMG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients should fulfill the &quot;Bologna criteria&quot; for poor ovarian response&#xD;
&#xD;
        At least two of the following three features must be present:&#xD;
&#xD;
        i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian&#xD;
        response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii.&#xD;
        An abnormal ovarian reserve test (i.e. AFC &lt;7 follicles or AMH &lt;1.1 ng/ml).&#xD;
&#xD;
        Two episodes of POR after maximal stimulation are sufficient to define a patient as poor&#xD;
        responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikolaos P Polyzos, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Reproductive Medicine UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <removed_countries>
    <country>Denmark</country>
  </removed_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>May 7, 2013</last_update_submitted>
  <last_update_submitted_qc>May 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Nikolaos P. Polyzos</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Poor ovarian response</keyword>
  <keyword>Poor ovarian responders</keyword>
  <keyword>Bologna criteria for poor ovarian response</keyword>
  <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>Triptorelin Pamoate</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/NCT01732068
org study id: 2012/082
nct id: NCT01732068
lead sponsor: 
has dmc: No
The purpose of the present study is to examine the level of ovarian response and the
      pregnancy rates among poor ovarian responders treated with a novel treatment protocol with
      150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.
Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after
      injection , a time interval which is significantly shorter as compared to treatment with
      rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration
      may result in a significantly higher exposure of the small antral follicles to constant high
      levels of FSH during the early follicular phase, securing not only the recruitment of the
      follicles, but also the continued growth.

      In the current study the investigators examine whether administration of corifollitropin
      followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy
      rates in poor ovarian responders fulfilling the "Bologna criteria"
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ongoing pregnancy rate
time frame: 10 to 12 weeks of gestation
measure: Number of oocytes retrieved
time frame: Day of oocyte retrieval
measure: Cycles with embryo transfer
time frame: Day of Embryo transfer
arm group label: Corifollitropin alfa+hMG
arm group type: Experimental
intervention type: Drug
intervention name: Triptorelin
description: Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
arm group label: Corifollitropin alfa+hMG
intervention type: Drug
intervention name: Corifollitropin alfa
description: Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
arm group label: Corifollitropin alfa+hMG
intervention type: Drug
intervention name: hpHMG
description: 300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
arm group label: Corifollitropin alfa+hMG
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Nikolaos P Polyzos, MD PhD
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Nikolaos P. Polyzos
investigator title: Principal investigator
mesh term: Infertility
mesh term: Triptorelin Pamoate