<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/NCT02209168</url>
  </required_header>
  <id_info>
    <org_study_id>1405-MAD-020-JG</org_study_id>
    <nct_id>NCT02209168</nct_id>
  </id_info>
  <brief_title>Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population</brief_title>
  <official_title>Differences in Ovarian Reserve Markers, Vitamin D Serum Levels and Reproductive Outcomes Between Infertile Indian, Arabian and Caucasian Population</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to confirm the difference in ovarian reserve markers and serum&#xD;
      vitamine D levels between infertile indian, arabian and caucasian population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 caucasian, indian, and arab patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count</measure>
    <time_frame>beginning of the treatment cycle</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum vitamin D levels</measure>
    <time_frame>Beginning of their treatment cycle</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Female Infertility Due to Diminished Ovarian Reserve</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>Hormone Deficiency</condition>
  <condition>Follicular Cyst of Ovary</condition>
  <arm_group>
    <arm_group_label>Infertile Indian Population</arm_group_label>
    <description>200 Infertile Indian population</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infertile arabian population</arm_group_label>
    <description>200 Infertile Arabian population</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infertile caucasian population</arm_group_label>
    <description>200 Infertile Caucasian population</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Vitamine D serum levels.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERTILIZATION TREATMENT DUE TO TUBAL,&#xD;
        MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL,&#xD;
        MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CARLOS IGLESIAS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVI Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 31, 2018</last_update_submitted>
  <last_update_submitted_qc>August 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2018</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>Carlos Iglesias, MD</investigator_title>
  </responsible_party>
  <keyword>AMH, ACF, VIT D, Ethnicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicular Cyst</mesh_term>
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Vitamin D Deficiency</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/NCT02209168
org study id: 1405-MAD-020-JG
nct id: NCT02209168
lead sponsor: 
has dmc: Yes
The aim of this study is to confirm the difference in ovarian reserve markers and serum
      vitamine D levels between infertile indian, arabian and caucasian population.
200 caucasian, indian, and arab patients
observational model: Cohort
time perspective: Prospective
measure: Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count
time frame: beginning of the treatment cycle
measure: Serum vitamin D levels
time frame: Beginning of their treatment cycle
arm group label: Infertile Indian Population
description: 200 Infertile Indian population
arm group label: Infertile arabian population
description: 200 Infertile Arabian population
arm group label: Infertile caucasian population
description: 200 Infertile Caucasian population
Vitamine D serum levels.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 43 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CARLOS IGLESIAS, MD
role: Principal Investigator
affiliation: IVI Madrid
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: IVI Madrid
investigator full name: Juan A Garcia-Velasco
investigator title: Carlos Iglesias, MD
mesh term: Follicular Cyst
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Vitamin D Deficiency