Uterus Transplantation From Live Donor (utx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01844362|
Recruitment Status : Unknown
Verified November 2016 by Mats Brännström, Sahlgrenska University Hospital, Sweden.
Recruitment status was: Active, not recruiting
First Posted : May 1, 2013
Last Update Posted : November 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Uterine Infertility||Procedure: uterine transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Case Series of Human Uterus Transplantation From Live Donor|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
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.
- surviving transplants (12 months) [ Time Frame: up to 3 years after transplantation ]
- pregnancy rate [ Time Frame: up to 3 years after transplantation ]
- live birth rate [ Time Frame: up to 4 years after transplantation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844362
|Göteborg, Sweden, SE-41345|
|Principal Investigator:||Mats Brännström, MD, PhD||Göteborg University|