Uterus Transplantation From Live Donor (utx)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Case Series of Human Uterus Transplantation From Live Donor|
- surviving transplants (12 months) [ Time Frame: up to 3 years after transplantation ] [ Designated as safety issue: Yes ]
- pregnancy rate [ Time Frame: up to 3 years after transplantation ] [ Designated as safety issue: Yes ]
- live birth rate [ Time Frame: up to 4 years after transplantation ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844362
|Göteborg, Sweden, SE-41345|
|Principal Investigator:||Mats Brännström, MD, PhD||Göteborg University|