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

Not Applicable

Recruiting

• Conditions: Mayer Rokitansky Kuster Hauser Syndrome
• Interventions: Procedure: Uterine transplantation

• Registration Number: NCT03689842
• Lead Sponsor: Hopital Foch

Brief Summary

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

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 Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-12-14
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Couple donor - recipient	Uterine transplantation	-

Primary Outcome Measures

Name	Time	Method
Pregnancy	3 years	Obtaining of a pregnancy after uterine transplantation from a living donor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France