<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/NCT03784157</url>
  </required_header>
  <id_info>
    <org_study_id>7222</org_study_id>
    <nct_id>NCT03784157</nct_id>
  </id_info>
  <brief_title>Study Of The Metabolic Parameters Of Uterine Muscle Cells</brief_title>
  <official_title>Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of&#xD;
      the main reservations lies in the ischemic properties of the uterine graft between the&#xD;
      sampling time and the grafting time.&#xD;
&#xD;
      Investigators propose to carry out a prospective monocentric study at the University&#xD;
      Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the&#xD;
      time of ischemia of the uterine muscle The objective is to carry out a preparatory study on&#xD;
      healthy uteri to study the ischemic properties of uterine muscle from living markers: study&#xD;
      of mitochondrial respiration and free radical production on uterine muscle samples If the&#xD;
      markers are reliable, they would then be used to measure the ischemia of whole uteri&#xD;
      collected at the end of the multi-organ retrieval process from donors in a state of brain&#xD;
      death and stored in tissue survival media.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">December 13, 2020</completion_date>
  <primary_completion_date type="Actual">December 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ischemia</measure>
    <time_frame>1 hour after sampling</time_frame>
    <description>Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Ischemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient benefiting from the routine management of a programmed hysterectomy by vaginal,&#xD;
        laparoscopic or laparotomy for benign pathologies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  - Adult patient&#xD;
&#xD;
          -  Patient benefiting from the routine management of a programmed hysterectomy by&#xD;
             vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis,&#xD;
             genital prolapse,...) within the CMCO&#xD;
&#xD;
          -  Patient consenting to the use of cells from her uterus for incineration for research&#xD;
             purposes&#xD;
&#xD;
          -  Patient giving her consent for the use of her medical data for the purposes of this&#xD;
             research.&#xD;
&#xD;
          -  Patient agreeing to participate in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  - Patient refusing to participate in the study&#xD;
&#xD;
          -  Patient under the protection of justice&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Suspicion of gynaecological malignant pathology&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Impossibility to give the subject informed information (difficulties in understanding&#xD;
             the subject...)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Olivier GARBIN, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Gynécologie - CMCO</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hysterotomy</keyword>
  <keyword>UTERINE MUSCLE CELLS</keyword>
  <keyword>ISCHEMIA</keyword>
  <keyword>COLD ISCHEMIA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</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/NCT03784157
org study id: 7222
nct id: NCT03784157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of
      the main reservations lies in the ischemic properties of the uterine graft between the
      sampling time and the grafting time.

      Investigators propose to carry out a prospective monocentric study at the University
      Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the
      time of ischemia of the uterine muscle The objective is to carry out a preparatory study on
      healthy uteri to study the ischemic properties of uterine muscle from living markers: study
      of mitochondrial respiration and free radical production on uterine muscle samples If the
      markers are reliable, they would then be used to measure the ischemia of whole uteri
      collected at the end of the multi-organ retrieval process from donors in a state of brain
      death and stored in tissue survival media.
observational model: Other
time perspective: Prospective
measure: Ischemia
time frame: 1 hour after sampling
description: Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Olivier GARBIN, MD
role: Study Director
affiliation: University Hospital, Strasbourg, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Ischemia