Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)

Hopital Foch20 enrolled

Overview

In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are: * Gestational surrogacy, prohibited in France * Adoption * Resignation Uterine transplantation could become a good alternative. This study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus

The aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. Also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mayer Rokitansky Kuster Hauser Syndrome

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations): * Being aged between 18 and 38 years old * In stable couple, with a pregnancy project, favorable psychological evaluation * No history of cancer and transfusion The living donor is a woman related to the Graft recipient with * Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology) * Absence of uterine surgery, abdomino-pelvic major pathology history Exclusion Criteria: Graft recipient: * Extreme oligo-astheno-spermia and azoospermia in the husband * History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis Living donor : * Known thromboembolic risk factor * No Compatibility with the recipient (group, rhesus, HLA)

Outcomes

Primary Outcomes

Pregnancy

Obtaining of a pregnancy after uterine transplantation from a living donor

Time frame: 3 years

Secondary Outcomes

Safety assessment of the donor, the recipient and the fœtus

Monitoring of all the Adverse events

Time frame: 7 years

Psychological assessment of the donor and the recipient

Psychological consequences linked to the procedure determined by repeated interviews with psychologists

Time frame: 7 years

Graft Rejection assessment

Donor-specific antobodies monitoring

Time frame: 5 years