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NCT Number: NCT03689842

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

Recruiting

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Key information

Conditions

Mayer Rokitansky Kuster Hauser Syndrome Mullerian aplasia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

Location status: Recruiting

Location contact

Aurélie Revaux, MD

SUB_INVESTIGATOR

Jean-Marc Ayoubi, MD PhD

CONTACT

[email protected]

+33(0)146252339

Jean-Marc Ayoubi, MD PhD

PRINCIPAL_INVESTIGATOR

Marie Carbonnel, MD

SUB_INVESTIGATOR

René Frydman, MD PhD

SUB_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

uterine transplantation

Procedure

Uterine transplantation from living donor

Primary outcomes

  1. Pregnancy

    Time frame: 3 years

    Obtaining of a pregnancy after uterine transplantation from a living donor

Secondary outcomes

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

    Time frame: 7 years

    Monitoring of all the Adverse events

  2. Psychological assessment of the donor and the recipient

    Time frame: 7 years

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

  3. Graft Rejection assessment

    Time frame: 5 years

    Donor-specific antobodies monitoring

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2034
First posted
Sep 28, 2018
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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