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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

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

Conditions
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Mayer Rokitansky Kuster Hauser Syndrome

Intervention / Treatment
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* Procedure: Uterine transplantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Couple donor - recipient<br> | Procedure: Uterine transplantation<br>* Uterine transplantation from living donor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Obtaining of a pregnancy after uterine transplantation from a living donor | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment of the donor, the recipient and the fœtus | Monitoring of all the Adverse events | 7 years | 
| Psychological assessment of the donor and the recipient | Psychological consequences linked to the procedure determined by repeated interviews with psychologists | 7 years | 
| Graft Rejection assessment | Donor-specific antobodies monitoring | 5 years |