Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC (GOT-BMC-UTx)

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

Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.

Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

Study Type

Interventional

Enrollment (Actual)

2

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
      • Gothenburg, Sweden, 41345
        • Sahlgrenska University Hospital
      • 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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria recipient

  • age < 38 years
  • psychologicaly stable
  • BMI < 35
  • no systemic disease
  • no standing medication
  • in a stable relationship or married
  • normal ovarian reserve
  • absolute uterine factor infertility
  • normal kidney function

Inclusion criteria donor

  • close relative to recipient
  • age < 60 years
  • normal pregnancies
  • maximum two cesarean sections
  • BMI < 35
  • no major systemic disease
  • no previous major surgery

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: uterus transplantation
uterus transplantation from living donor with the donor being close relative
Procedure: uterus transplantation surgery and IVF
IVF before surgery living donor uterus transplantation ET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth
Time Frame: 3 years
live birth
3 years

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Saint Joseph University, at Bellevue Medical Centre

Investigators

  • Principal Investigator: Mats Brännström, MD, PhD, Sahlgrenska University Hospital, Sweden

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)

June 15, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 17, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 18, 2018

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

  • Sahlgrenska-BMC-UTx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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