<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/NCT01672931</url>
  </required_header>
  <id_info>
    <org_study_id>0034-12 HYMC</org_study_id>
    <nct_id>NCT01672931</nct_id>
  </id_info>
  <brief_title>The Association Between Overweight and Oocyte Diameter in Women Undergoing Vitro Fertilization</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>
      We believe that there is an association between BMI and oocyte diameter in women undergoing&#xD;
      IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF.&#xD;
      One group will have BMI 20-25 and the other group will have BMI above 30.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>Larger Size of Oocyte Diameter</measure>
    <time_frame>One year</time_frame>
    <description>Oocyte will be measured in women undergoing IVF treatment</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Infertility</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>BMI over 30</arm_group_label>
    <description>Women undergoing IVF with BMI over 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 20-25</arm_group_label>
    <description>Women undergoing IVF treatments with BMI between 20-25</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oocyte Measurement</intervention_name>
    <arm_group_label>BMI 20-25</arm_group_label>
    <arm_group_label>BMI over 30</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing IVF treatments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF treated patients&#xD;
&#xD;
          -  BMI between 20-25 or over 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Everyone else&#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_official>
    <last_name>Gai Shrem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gai Shrem, MD</last_name>
    <phone>972-50-6793080</phone>
    <email>gai.shrem@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2012</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>
  </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/NCT01672931
org study id: 0034-12 HYMC
nct id: NCT01672931
lead sponsor: 
has dmc: Yes
We believe that there is an association between BMI and oocyte diameter in women undergoing
      IVF treatments. We plan to measure the oocyte diameter in 2 groups of women undergoing IVF.
      One group will have BMI 20-25 and the other group will have BMI above 30.
observational model: Case-Control
time perspective: Prospective
measure: Larger Size of Oocyte Diameter
time frame: One year
description: Oocyte will be measured in women undergoing IVF treatment
arm group label: BMI over 30
description: Women undergoing IVF with BMI over 30
arm group label: BMI 20-25
description: Women undergoing IVF treatments with BMI between 20-25
intervention type: Other
intervention name: Oocyte Measurement
arm group label: BMI 20-25
arm group label: BMI over 30
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Gai Shrem, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Gai Shrem, MD
phone: 972-50-6793080
email: gai.shrem@gmail.com
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Infertility