Uterus Transplantation From Live Donor (utx)

December 14, 2021 updated by: Mats Brännström, Sahlgrenska University Hospital, Sweden

Prospective Case Series of Human Uterus Transplantation From Live Donor

Uterus transplantation, as a possible future treatment for uterine factor infertility, has been developed in animal species during the last decade.

The study protocol includes transplantation of the uterus from a live donor (mother, relative, friend) into women with absolute uterine factor infertility (lack of uterus from birth or due to life saving hysterectomy).The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted when at least 12 months have passed from transplantation. Approval for a case series including up to 10 patients has been acquired.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is ongoing, with inclusion of 9 patients.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, SE-41345
        • Mats Brännström

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • less than 39 years
  • good general health

Exclusion Criteria:

  • poor ovarian resaerve or older than 39 years
  • systemic or psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Uterine transplantation
Patients undergo transplantation of the uterus from live donor.
Procedure: uterine transplantation
Transplantation of the uterus from live donor and IVF treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
surviving transplants (12 months)
Time Frame: up to 3 years after transplantation
up to 3 years after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: up to 3 years after transplantation
up to 3 years after transplantation

Other Outcome Measures

Outcome Measure
Time Frame
live birth rate
Time Frame: up to 4 years after transplantation
up to 4 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

The Swedish Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • utx-ld

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Scientific publications

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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