<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/NCT01683513</url>
  </required_header>
  <id_info>
    <org_study_id>Dr. Decleer W</org_study_id>
    <nct_id>NCT01683513</nct_id>
  </id_info>
  <brief_title>Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients</brief_title>
  <official_title>Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AZ Jan Palfijn Gent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AZ Jan Palfijn Gent</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators compare the traditional way of triggering with a new way in&#xD;
      patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper&#xD;
      Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/&#xD;
      ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and&#xD;
      pregnancy rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MII oocytes</measure>
    <time_frame>patients will be followed during the stimulation with an average of 10 days</time_frame>
    <description>The number of mature oocytes retrieved after stimulation without creating OHSS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2 Pro Nuclei (2PN) fertilization</measure>
    <time_frame>24h after ICSI</time_frame>
    <description>laboratory follow up of the fertilized egg during the first 24h</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>implantation rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of pregnancies obtained wich still is the most important issue for the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OHSS</measure>
    <time_frame>one month with oocyte retrieval in the middle</time_frame>
    <description>patient follow up according to subjective complaints and objective measures</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Infertility</condition>
  <condition>PCOS</condition>
  <arm_group>
    <arm_group_label>humaan chorion gonadotropine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>ovulation induction with 5000E hCG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GnRH agonist + 1500E hCG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRh agonist +1500E hCG</intervention_name>
    <description>ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval</description>
    <arm_group_label>GnRH agonist + 1500E hCG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICSI patients below 38 years&#xD;
&#xD;
          -  1, 2 and 3e IVF cycle&#xD;
&#xD;
          -  Body Mass Index (BMI) less than 32&#xD;
&#xD;
          -  PCOS patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endocrinal diseases or problems&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wim Decleer, gynecologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVF Centrum Jan Palfijn Gent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Jan Palfijn</name>
      <address>
        <city>Gent</city>
        <state>Oost-vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AZ Jan Palfijn Gent</investigator_affiliation>
    <investigator_full_name>Dr. Decleer Wim</investigator_full_name>
    <investigator_title>gynecologist</investigator_title>
  </responsible_party>
  <keyword>OHSS</keyword>
  <keyword>mataphase II oocytes (MII)</keyword>
  <keyword>good quality embryo's</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT01683513
org study id: Dr. Decleer W
nct id: NCT01683513
lead sponsor: 
collaborator: 
has dmc: Yes
In this study the investigators compare the traditional way of triggering with a new way in
      patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper
      Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/
      ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and
      pregnancy rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MII oocytes
time frame: patients will be followed during the stimulation with an average of 10 days
description: The number of mature oocytes retrieved after stimulation without creating OHSS
measure: 2 Pro Nuclei (2PN) fertilization
time frame: 24h after ICSI
description: laboratory follow up of the fertilized egg during the first 24h
measure: implantation rate
time frame: 12 weeks
description: The number of pregnancies obtained wich still is the most important issue for the patients
measure: OHSS
time frame: one month with oocyte retrieval in the middle
description: patient follow up according to subjective complaints and objective measures
arm group label: humaan chorion gonadotropine
arm group type: No Intervention
description: ovulation induction with 5000E hCG
arm group label: GnRH agonist + 1500E hCG
arm group type: Active Comparator
description: ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval
intervention type: Drug
intervention name: GnRh agonist +1500E hCG
description: ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval
arm group label: GnRH agonist + 1500E hCG
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Wim Decleer, gynecologist
role: Principal Investigator
affiliation: IVF Centrum Jan Palfijn Gent
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: AZ Jan Palfijn Gent
investigator full name: Dr. Decleer Wim
investigator title: gynecologist
mesh term: Infertility