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

Hopital Foch

Status: Enrolling

Conditions: Mayer Rokitansky Kuster Hauser Syndrome

Treatments: Procedure: Uterine transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03689842

2016/26

Details and patient eligibility

About

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

Full description

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)

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Couple donor - recipient

Experimental group

Treatment:

Procedure: Uterine transplantation