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

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

Study Overview

• Status: Recruiting
• Conditions: Mayer Rokitansky Kuster Hauser Syndrome
• Intervention / Treatment: Procedure: Uterine transplantation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hopital Foch
    • Contact: Jean-Marc Ayoubi, MD PhD; Phone Number: +33(0)146252339; Email: jm.ayoubi@hopital-foch.org
    • Principal Investigator: Jean-Marc Ayoubi, MD PhD
    • Sub-Investigator: René Frydman, MD PhD
    • Sub-Investigator: Marie Carbonnel, MD
    • Sub-Investigator: Aurélie Revaux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couple donor - recipient	Procedure: Uterine transplantation; Uterine transplantation from living donor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch

Publications and helpful links

General Publications

• Goetgheluck J, Carbonnel M, Ayoubi JM. Robotically assisted gynecologic surgery: 2-year experience in the French foch hospital. Front Surg. 2014 May 5;1:8. doi: 10.3389/fsurg.2014.00008. eCollection 2014.
• Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.
• Carbonnel M, Abbou H, N'guyen HT, Roy S, Hamdi G, Jnifen A, Ayoubi JM. Robotically Assisted Hysterectomy versus Vaginal Hysterectomy for Benign Disease: A Prospective Study. Minim Invasive Surg. 2013;2013:429105. doi: 10.1155/2013/429105. Epub 2013 Jul 7.
• Gauthier T, Lavoue V, Piver P, Aubard Y, Ayoubi JM, Garbin O, Agostini A, Collinet P, Morcel K; Comite d'etude de la Transplantation Uterine en France (CETUF) du CNGOF. Which neovagina reconstruction procedure for women with Mayer-Rokitansky-Kuster-Hauser syndrome in the uterus transplantation era? Editorial from the French Uterus Transplantation Committee (CETUF) of CNGOF. J Gynecol Obstet Hum Reprod. 2018 Apr;47(4):175-176. doi: 10.1016/j.jogoh.2018.01.003. Epub 2018 Jan 31. No abstract available.
• Grynberg M, Ayoubi JM, Bulletti C, Frydman R, Fanchin R. Uterine transplantation: a promising surrogate to surrogacy? Ann N Y Acad Sci. 2011 Mar;1221:47-53. doi: 10.1111/j.1749-6632.2011.05952.x.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): December 14, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Syndrome; 46, XX Disorders of Sex Development
• Other Study ID Numbers: 2016/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No