Uterus Transplantation From Deceased Donor - Gothenburg III

December 14, 2021 updated by: Mats Brännström, Sahlgrenska University Hospital, Sweden
Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

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 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria recipient

  • initially included with IVF and excluded by donor issues of Gothenburg I or II
  • initially included and excluded by early graft failure of Gothenburg I or II
  • age < 40 years
  • no systemic disease
  • no standing medication
  • satisfactory ovarian reserve
  • BMI <35 and at BMI 30-35 waist circumference of < 82 cm
  • absolute uterine factor infertility
  • psychological stable

Inclusion criteria donor

  • brain death and suitable as multiorgan donor
  • acceptance for donation of uterus from family or previously by patient
  • age <55 years
  • at least one normal pregnancy and childbirth
  • no previos malignancy
  • no systemic disease
  • no previous major surgery inn abdomen or on uterus

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Uterus transplantation
Procedure: uterus transplantation
uterus transplantation from deceased donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
birth of healthy child
Time Frame: 1-5 years after transplantation
1-5 years after transplantation

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Mats Brännström, Göteborg University

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 17, 2018

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

June 17, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (ACTUAL)

July 10, 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-DD-UTx

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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