<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/NCT01671215</url>
  </required_header>
  <id_info>
    <org_study_id>MMC120026CTIL</org_study_id>
    <nct_id>NCT01671215</nct_id>
  </id_info>
  <brief_title>Endometrial and Myometrial Changes, With and Without Fibroids</brief_title>
  <official_title>Endometrial and Myometrial Changes, With and Without Fibroids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      fibroids are common among women in fertile age. the relation between fibroids and infertility&#xD;
      is controversial. our goal is to claculate a ratio between uterine cavity - endometrium &amp;&#xD;
      myometrium in normal uterine s and study the interference of the cavity in uterine s with&#xD;
      fibroids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      phase 1-&#xD;
&#xD;
        1. retrospective measurments of uterine dimensions of 100 women with normal uterin&#xD;
&#xD;
        2. measurment of the above during different sycle days in the same woman. 30 women.&#xD;
&#xD;
      phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3-&#xD;
      the same for 400 uterine malformations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no enrollment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">August 2014</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>ratio between normal &amp; abnormal(by fibroid) uterine cavity</measure>
    <time_frame>year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ratio between endometriom &amp; myometrium area, circumference &amp;n volume</measure>
    <time_frame>year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Fibroids</condition>
  <eligibility>
    <study_pop>
      <textblock>
        women at the age of 20-45&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women at IVF unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inabilty to measure propperly the uterine dimensions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ronni tepper, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir medical center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>April 14, 2015</last_update_submitted>
  <last_update_submitted_qc>April 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endometrium</keyword>
  <keyword>myometrium</keyword>
  <keyword>fibroids</keyword>
  <keyword>uterine malformations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</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/NCT01671215
org study id: MMC120026CTIL
nct id: NCT01671215
lead sponsor: 
has dmc: No
fibroids are common among women in fertile age. the relation between fibroids and infertility
      is controversial. our goal is to claculate a ratio between uterine cavity - endometrium &
      myometrium in normal uterine s and study the interference of the cavity in uterine s with
      fibroids.
phase 1-

        1. retrospective measurments of uterine dimensions of 100 women with normal uterin

        2. measurment of the above during different sycle days in the same woman. 30 women.

      phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3-
      the same for 400 uterine malformations
observational model: Cohort
time perspective: Prospective
measure: ratio between normal & abnormal(by fibroid) uterine cavity
time frame: year
measure: ratio between endometriom & myometrium area, circumference &n volume
time frame: year
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ronni tepper, md
role: Principal Investigator
affiliation: Tel Aviv University
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma