<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/NCT02210013</url>
  </required_header>
  <id_info>
    <org_study_id>MAD-CI-01-2012-01</org_study_id>
    <nct_id>NCT02210013</nct_id>
  </id_info>
  <brief_title>Differences in Ovarian Aging Between Caucasian and Indian Women</brief_title>
  <official_title>Ethnicity as a Determinant of Ovarian Aging: Differences Between Caucasian and Indian Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVI Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian&#xD;
      women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The&#xD;
      investigators will collect data about ovarian reserve markers and also the results after&#xD;
      ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian&#xD;
      response after IVF stimulation between both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second&#xD;
      IVF cycle will be included.&#xD;
&#xD;
      The date we will collect in both groups include the age, the body mass index, and the ovarian&#xD;
      reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH)&#xD;
      and antimullerian hormone (AMH) serum levels.&#xD;
&#xD;
      The investigators will also determine the number of oocytes retrieved and the metaphase two&#xD;
      oocytes in both groups after IVF stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>11 Months</target_duration>
  <primary_outcome>
    <measure>AMH levels produced by granulosa cells</measure>
    <time_frame>day 1</time_frame>
    <description>AMH levels (ng/mL) as well as AFC in both ethnic groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes</measure>
    <time_frame>day 1</time_frame>
    <description>The number of oocytes retrieved as well as the mature oocytes after IVF ovarian stimulation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Age of the Patients and the Body Mass Index in Both Groups</condition>
  <arm_group>
    <arm_group_label>Caucasian women</arm_group_label>
    <description>200 Caucasian infertile women undergoing their first or second IVF cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indian women</arm_group_label>
    <description>200 Indian women undergoing their first or second IVF cycle.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Caucasian infertile women and Indican infertile women age &lt; 42 years old, with both ovaries&#xD;
        present, undergoing an IVF treatment due to male factor, tubal disease or previous failed&#xD;
        IUI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged &lt; 42 years old, with both ovaries present, undergoing a first or second IVF&#xD;
             treatment due to male factor, tubal disease or previous failed intrauterine&#xD;
             insemination (IUI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed of polycystic ovary syndrome according to Rotterdam criteria,&#xD;
             endometriosis stage III-IV, or previous pelvic inflammatory disease.&#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>Carlos Iglesias, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manish Banker, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NOVA IVI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nalini Mahajan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NOVA IVI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leyre Herrero, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio Pellicer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI VALENCIA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Antonio Garcia-Velasco, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IVI Madrid</investigator_affiliation>
    <investigator_full_name>Juan A Garcia-Velasco</investigator_full_name>
    <investigator_title>Juan A Garcia-Velasco, MD, Phd</investigator_title>
  </responsible_party>
  <keyword>AMH, AFC, aging, ethnicity</keyword>
  <!-- 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/NCT02210013
org study id: MAD-CI-01-2012-01
nct id: NCT02210013
lead sponsor: 
has dmc: No
The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian
      women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The
      investigators will collect data about ovarian reserve markers and also the results after
      ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian
      response after IVF stimulation between both groups.
A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second
      IVF cycle will be included.

      The date we will collect in both groups include the age, the body mass index, and the ovarian
      reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH)
      and antimullerian hormone (AMH) serum levels.

      The investigators will also determine the number of oocytes retrieved and the metaphase two
      oocytes in both groups after IVF stimulation.
observational model: Cohort
time perspective: Prospective
measure: AMH levels produced by granulosa cells
time frame: day 1
description: AMH levels (ng/mL) as well as AFC in both ethnic groups.
measure: Number of oocytes
time frame: day 1
description: The number of oocytes retrieved as well as the mature oocytes after IVF ovarian stimulation
arm group label: Caucasian women
description: 200 Caucasian infertile women undergoing their first or second IVF cycle
arm group label: Indian women
description: 200 Indian women undergoing their first or second IVF cycle.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Carlos Iglesias, M.D.
role: Principal Investigator
affiliation: IVI Madrid
last name: Manish Banker, M.D.
role: Principal Investigator
affiliation: NOVA IVI
last name: Nalini Mahajan, M.D.
role: Principal Investigator
affiliation: NOVA IVI
last name: Leyre Herrero, Ph. D.
role: Principal Investigator
affiliation: IVI Madrid
last name: Antonio Pellicer, M.D.
role: Principal Investigator
affiliation: IVI VALENCIA
last name: Juan Antonio Garcia-Velasco, M.D.
role: Principal Investigator
affiliation: IVI Madrid
responsible party type: Principal Investigator
investigator affiliation: IVI Madrid
investigator full name: Juan A Garcia-Velasco
investigator title: Juan A Garcia-Velasco, MD, Phd