<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/NCT03020173</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0098-16</org_study_id>
    <nct_id>NCT03020173</nct_id>
  </id_info>
  <brief_title>The Difference Seen in Granulosa Cells and Immature Oocytes in IVF Treated Patients Sorted by Body Mass Index (BMI)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to discover the connection between BMI and oocyte and granulosa&#xD;
      consistencies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of composition of granulosa cells and oocytes</measure>
    <time_frame>One year</time_frame>
    <description>Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>BMI above 30</arm_group_label>
    <description>Oocytes and granulosa of infertile women with BMI above 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI below 30</arm_group_label>
    <description>Oocytes and granulosa of infertile women with BMI above 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory study</intervention_name>
    <description>Laboratory analysis to determine composition of granulosa and oocytes</description>
    <arm_group_label>BMI above 30</arm_group_label>
    <arm_group_label>BMI below 30</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile women undergoing IVF treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women undergoing IVF&#xD;
&#xD;
          -  Consent to participate in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fertility preservation due to cancer&#xD;
&#xD;
          -  Endocrine disorders&#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_contact>
    <last_name>Rinat Lift, MSc</last_name>
    <email>rinatl@hy.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shira Raviv, MD</last_name>
    <email>drshiraraviv@gmail.com</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03020173
org study id: HYMC-0098-16
nct id: NCT03020173
lead sponsor: 
has dmc: Yes
This study aims to discover the connection between BMI and oocyte and granulosa
      consistencies.
observational model: Case-Control
time perspective: Prospective
measure: Measurement of composition of granulosa cells and oocytes
time frame: One year
description: Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels
arm group label: BMI above 30
description: Oocytes and granulosa of infertile women with BMI above 30
arm group label: BMI below 30
description: Oocytes and granulosa of infertile women with BMI above 30
intervention type: Other
intervention name: Laboratory study
description: Laboratory analysis to determine composition of granulosa and oocytes
arm group label: BMI above 30
arm group label: BMI below 30
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Rinat Lift, MSc
email: rinatl@hy.health.gov.il
last name: Shira Raviv, MD
email: drshiraraviv@gmail.com
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No