Overview

This trial is active, not recruiting.

Condition primary uterine infertility
Treatment uterine transplantation
Sponsor Sahlgrenska University Hospital, Sweden
Collaborator The Swedish Research Council
Start date September 2012
End date April 2018
Trial size 10 participants
Trial identifier NCT01844362, utx-ld

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo transplantation of the uterus from live donor.
uterine transplantation
Transplantation of the uterus from live donor and IVF treatment.

Primary Outcomes

Measure
surviving transplants (12 months)
time frame: up to 3 years after transplantation

Secondary Outcomes

Measure
pregnancy rate
time frame: up to 3 years after transplantation

Eligibility Criteria

Female participants from 18 years up to 39 years old.

Inclusion Criteria: - less than 39 years - good general health Exclusion Criteria: - poor ovarian resaerve or older than 39 years - systemic or psychiatric disease

Additional Information

Official title Prospective Case Series of Human Uterus Transplantation From Live Donor
Principal investigator Mats Brännström, MD, PhD
Description The study is ongoing, with inclusion of 9 patients.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sahlgrenska University Hospital, Sweden.