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

Mayer Rokitansky Kuster Hauser Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689842
• Other study ID #: 2016/26
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mayer Rokitansky Kuster Hauser Syndrome
• Syndrome

Intervention

Procedure:
• Uterine transplantation
Uterine transplantation from living donor

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Obtaining of a pregnancy after uterine transplantation from a living donor	3 years
Secondary	Safety assessment of the donor, the recipient and the fœtus	Monitoring of all the Adverse events	7 years
Secondary	Psychological assessment of the donor and the recipient	Psychological consequences linked to the procedure determined by repeated interviews with psychologists	7 years
Secondary	Graft Rejection assessment	Donor-specific antobodies monitoring	5 years