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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2034-12-14

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

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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)

Conditions

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Mayer Rokitansky Kuster Hauser Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Couple donor - recipient

Group Type EXPERIMENTAL

Uterine transplantation

Intervention Type PROCEDURE

Uterine transplantation from living donor

Interventions

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Uterine transplantation

Uterine transplantation from living donor

Intervention Type PROCEDURE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes