<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/NCT02987023</url>
  </required_header>
  <id_info>
    <org_study_id>SahlgrenskaUTx</org_study_id>
    <nct_id>NCT02987023</nct_id>
  </id_info>
  <brief_title>Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II</brief_title>
  <acronym>UTX-robot</acronym>
  <official_title>Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a follow up of NCT01844362. Uterus transplantation will be performed from live&#xD;
      donors to patients with uterine factor infertility. If will be performed before&#xD;
      transplantation. Organ procurement from the donor will be performed by robotic assisted&#xD;
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months&#xD;
      after transplantation. After birth of 1-3 children the uterus will be removed by&#xD;
      hysterectomy,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a follow up of NCT01844362. Uterus transplantation will be performed from live&#xD;
      donors to patients with uterine factor infertility. If will be performed before&#xD;
      transplantation. Organ procurement from the donor will be performed by robotic assisted&#xD;
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months&#xD;
      after transplantation. After birth of 1-3 children the uterus will be removed by&#xD;
      hysterectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>7 Years</target_duration>
  <primary_outcome>
    <measure>Live births after uterus transplantation</measure>
    <time_frame>5 years</time_frame>
    <description>Assessed by records from birthing unit and Swedish National Birth registry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of children after uterus transplantation</measure>
    <time_frame>8 years</time_frame>
    <description>Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)</description>
  </secondary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Infertility, Female</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>uterus transplantation</intervention_name>
    <description>Uterus transplantation from live donor</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, endometrial tissue, cervical tissue, placental tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        absolute uterine factor infertile women &gt; 38 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age below 38 years&#xD;
&#xD;
          -  absolute uterine factor infertility&#xD;
&#xD;
          -  BMI&lt;30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease&#xD;
&#xD;
          -  psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mats Brännström, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Mats Brännström</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>infertility, uterus, transplantation</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual data will not be shared.</ipd_description>
  </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/NCT02987023
org study id: SahlgrenskaUTx
nct id: NCT02987023
lead sponsor: 
has dmc: Yes
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live
      donors to patients with uterine factor infertility. If will be performed before
      transplantation. Organ procurement from the donor will be performed by robotic assisted
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months
      after transplantation. After birth of 1-3 children the uterus will be removed by
      hysterectomy,
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live
      donors to patients with uterine factor infertility. If will be performed before
      transplantation. Organ procurement from the donor will be performed by robotic assisted
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months
      after transplantation. After birth of 1-3 children the uterus will be removed by
      hysterectomy.
observational model: Cohort
time perspective: Prospective
measure: Live births after uterus transplantation
time frame: 5 years
description: Assessed by records from birthing unit and Swedish National Birth registry
measure: Development of children after uterus transplantation
time frame: 8 years
description: Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)
intervention type: Procedure
intervention name: uterus transplantation
description: Uterus transplantation from live donor
blood, endometrial tissue, cervical tissue, placental tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mats Brännström, MD, PhD
role: Principal Investigator
affiliation: Göteborg University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Mats Brännström
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No
ipd description: Individual data will not be shared.