<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/NCT03252795</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2016/0731</org_study_id>
    <nct_id>NCT03252795</nct_id>
  </id_info>
  <brief_title>Uterus Transplantation From a Multi-organ Donor</brief_title>
  <official_title>Uterus Transplantation From a Multi-organ Donor: A Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to&#xD;
      freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 3, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival of the uterus 1 year after transplantation</measure>
    <time_frame>1 year after uterus transplantation</time_frame>
    <description>Survival of the uterus 1 year after transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications after uterus transplantation</measure>
    <time_frame>As long as the uterus remains in situ (the uterus will be removed within one year after delivery)</time_frame>
    <description>Complications after uterus transplantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>4 weeks after embryo transfer</time_frame>
    <description>Ongoing pregnancy rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Take home baby rate</measure>
    <time_frame>9 months after embryo transfer</time_frame>
    <description>Take home baby rate</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Infertility, Female</condition>
  <condition>Mayer Rokitansky Kuster Hauser Syndrome</condition>
  <arm_group>
    <arm_group_label>Uterus transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>uterus transplantation</intervention_name>
    <description>transplantation of a uterus from a deceased donor</description>
    <arm_group_label>Uterus transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female with Maier-Rokitansky-Kuster-Hauser syndrome&#xD;
&#xD;
          -  Mucosal neovagina of at least 7 cm&#xD;
&#xD;
          -  In a stable relationship for at least 1 year&#xD;
&#xD;
          -  Child wish&#xD;
&#xD;
          -  Good renal function (and presence of both kidneys)&#xD;
&#xD;
          -  Psychologically stable and compliant&#xD;
&#xD;
          -  At least 8 frozen embryos after IVF/intracytoplasmic sperm injection [ICSI]&#xD;
&#xD;
          -  Living in Belgium and a good health insurance&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major pelvic surgery&#xD;
&#xD;
          -  Major chronic illnesses&#xD;
&#xD;
          -  Other risk factors or malignancies&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Steven Weyers, MD, PhD</last_name>
    <phone>+3293325446</phone>
    <email>steven.weyers@uzgent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Somers, MSc</last_name>
    <phone>+3293323757</phone>
    <email>Sara.Somers@uzgent.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ghent University Hospital - Women's Clinic</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>+3293322117</phone>
      <email>baarmoedertransplantatie@uzgent.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infertility, female</keyword>
  <keyword>Mayer Rokitansky Kuster Hauser Syndrome</keyword>
  <keyword>Transplantation; Deceased donor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>46, XX Disorders of Sex Development</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/NCT03252795
org study id: EC/2016/0731
nct id: NCT03252795
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to
      freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival of the uterus 1 year after transplantation
time frame: 1 year after uterus transplantation
description: Survival of the uterus 1 year after transplantation
measure: Complications after uterus transplantation
time frame: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
description: Complications after uterus transplantation
measure: Ongoing pregnancy rate
time frame: 4 weeks after embryo transfer
description: Ongoing pregnancy rate
measure: Take home baby rate
time frame: 9 months after embryo transfer
description: Take home baby rate
arm group label: Uterus transplantation
arm group type: Experimental
intervention type: Procedure
intervention name: uterus transplantation
description: transplantation of a uterus from a deceased donor
arm group label: Uterus transplantation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Steven Weyers, MD, PhD
phone: +3293325446
email: steven.weyers@uzgent.be
last name: Sara Somers, MSc
phone: +3293323757
email: Sara.Somers@uzgent.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: 46, XX Disorders of Sex Development