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RecruitingNCT03689842Updated Mar 7, 2025

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

An interventional study of Uterine transplantation in Mayer Rokitansky Kuster Hauser Syndrome, sponsored by Hopital Foch. Recruiting at 1 site in France. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Hopital Foch · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2017, registered Jul 2018).
  • Started Dec 2017; still recruiting 8 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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

Read the 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)

02

Conditions studied

  • Mayer Rokitansky Kuster Hauser Syndrome

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03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Couple donor - recipient

    Procedure: Uterine transplantation

Interventions

  • ProcedureUterine transplantation

    Uterine transplantation from living donor

06

What researchers measure

Primary outcomes

  1. Pregnancy

    Obtaining of a pregnancy after uterine transplantation from a living donor

    Time frame: 3 years

Secondary outcomes

  1. Safety assessment of the donor, the recipient and the fœtus

    Monitoring of all the Adverse events

    Time frame: 7 years

  2. Psychological assessment of the donor and the recipient

    Psychological consequences linked to the procedure determined by repeated interviews with psychologists

    Time frame: 7 years

  3. Graft Rejection assessment

    Donor-specific antobodies monitoring

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Hopital Foch
    Suresnes, 92150, France
    • Jean-Marc Ayoubi, MD PhD · Contact · jm.ayoubi@hopital-foch.org · +33(0)146252339
    • Jean-Marc Ayoubi, MD PhD · Principal investigator
    • René Frydman, MD PhD · Sub investigator
    • Marie Carbonnel, MD · Sub investigator
    • Aurélie Revaux, MD · Sub investigator
    Recruiting
08

References and documents

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. PubMed 25593933 ↗
  • 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. PubMed 25301505 ↗
  • 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. PubMed 23936645 ↗
  • 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. PubMed 29391294 ↗
  • 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. PubMed 21401629 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03689842
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Sep 28, 2018
Start date
Dec 14, 2017
Primary completion
Dec 14, 2027 (estimated)
Completion
Dec 14, 2034 (estimated)
Last update
Mar 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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