search
Back to results

Acceptance of Uterus Transplantation

Primary Purpose

Resolve Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Uterus transplantation
Sponsored by
University Women's Hospital Tübingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Resolve Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age below 40 years
  • absolute uterine factor infertility
  • BMI < 30

Exclusion Criteria:

  • systemic disease
  • psychiatric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Uterus transplantation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients who are interested in an uterus transplantation
    Number of patients from these who do have a potential donor
    Number of patients from these who do have a medical indication for an uterus transplantation

    Secondary Outcome Measures

    Full Information

    First Posted
    December 31, 2016
    Last Updated
    February 8, 2017
    Sponsor
    University Women's Hospital Tübingen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03048396
    Brief Title
    Acceptance of Uterus Transplantation
    Official Title
    Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Women's Hospital Tübingen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Transplantation of an uterus
    Detailed Description
    Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Resolve Infertility

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Uterus transplantation
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Uterus transplantation
    Primary Outcome Measure Information:
    Title
    Number of patients who are interested in an uterus transplantation
    Time Frame
    3 years
    Title
    Number of patients from these who do have a potential donor
    Time Frame
    3 years
    Title
    Number of patients from these who do have a medical indication for an uterus transplantation
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age below 40 years absolute uterine factor infertility BMI < 30 Exclusion Criteria: systemic disease psychiatric disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara Brucker, MD
    Organizational Affiliation
    Research Institute for Women's Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29270725
    Citation
    Brucker SY, Brannstrom M, Taran FA, Nadalin S, Konigsrainer A, Rall K, Scholler D, Henes M, Bosmuller H, Fend F, Nikolaou K, Notohamiprodjo M, Rosenberger P, Grasshoff C, Heim E, Kramer B, Reisenauer C, Hoopmann M, Kagan KO, Dahm-Kahler P, Kvarnstrom N, Wallwiener D. Selecting living donors for uterus transplantation: lessons learned from two transplantations resulting in menstrual functionality and another attempt, aborted after organ retrieval. Arch Gynecol Obstet. 2018 Mar;297(3):675-684. doi: 10.1007/s00404-017-4626-z. Epub 2017 Dec 21.
    Results Reference
    derived

    Learn more about this trial

    Acceptance of Uterus Transplantation

    We'll reach out to this number within 24 hrs