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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    20
  • sponsor
    Hopital Foch
Updated on 14 February 2022
Accepts healthy volunteers

Summary

In France, one in 4500 women is affected by the MayerRokitantskyKsterHauser (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)

Details
Condition Mayer Rokitansky Kuster Hauser Syndrome
Treatment Uterine transplantation
Clinical Study IdentifierNCT03689842
SponsorHopital Foch
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Graft recipient is a patient with Mayer-Rokitansky-Kster-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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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