<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/NCT03007043</url>
  </required_header>
  <id_info>
    <org_study_id>2016.Polymorphisms_COS</org_study_id>
    <nct_id>NCT03007043</nct_id>
  </id_info>
  <brief_title>Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response</brief_title>
  <official_title>Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Universitari Dexeus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Universitari Dexeus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as&#xD;
      well as other, less studied, gonadotropin polymorphisms between ovarian response groups,&#xD;
      following ovarian stimulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of the main FSH receptor polymorphism</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">364</enrollment>
  <condition>Fertility Disorders</condition>
  <arm_group>
    <arm_group_label>Normal responders</arm_group_label>
    <description>Normal response following IVF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suboptimal responders</arm_group_label>
    <description>Suboptimal response following IVF</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <arm_group_label>Normal responders</arm_group_label>
    <arm_group_label>Suboptimal responders</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile women undergoing ovarian stimulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-38 years old&#xD;
&#xD;
          2. BMI 18-28&#xD;
&#xD;
          3. Antral follicle count (AFC) &gt; 9 or Anti-mullerian hormone (AMH) &gt;1.1 ng/ml&#xD;
&#xD;
          4. 1st or 2nd ovarian stimulation cycle for IVF/ICSI&#xD;
&#xD;
          5. Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist&#xD;
             protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Antral follicle count (AFC) &lt;9 and AMH&lt;1.1 ng/ml&#xD;
&#xD;
          2. PCOS patients according to the Rotterdam criteria&#xD;
&#xD;
          3. Patients undergoing in vitro maturation (IVM)&#xD;
&#xD;
          4. Untreated endocrine abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dexeus Salud de la Mujer</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam and Research Center for Genetics and Reproductive Health (CGRH), School of Medicine, Vietnam National University HCMC</name>
      <address>
        <city>Ho Chi Minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Universitari Dexeus</investigator_affiliation>
    <investigator_full_name>Nikolaos Polyzos</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03007043
org study id: 2016.Polymorphisms_COS
nct id: NCT03007043
lead sponsor: 
has dmc: No
To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as
      well as other, less studied, gonadotropin polymorphisms between ovarian response groups,
      following ovarian stimulation
observational model: Cohort
time perspective: Prospective
measure: prevalence of the main FSH receptor polymorphism
time frame: 12 months
arm group label: Normal responders
description: Normal response following IVF
arm group label: Suboptimal responders
description: Suboptimal response following IVF
intervention type: Other
intervention name: blood sample
arm group label: Normal responders
arm group label: Suboptimal responders
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
facility: 
facility: 
country: Spain
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Institut Universitari Dexeus
investigator full name: Nikolaos Polyzos
investigator title: Professor