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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorHopital Foch

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being aged between 18 and 38 years old

In stable couple, with a pregnancy project, favorable psychological evaluation

No history of cancer and transfusion

Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)

Disqualifiers

Extreme oligo-astheno-spermia and azoospermia in the husband

History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis

Known thromboembolic risk factor

No Compatibility with the recipient (group, rhesus, HLA)

Trial design

Design model

Single group

Treatments tested in this trial

  • Uterine transplantation

    Procedure/Surgery

    Uterine transplantation from living donor

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Couple donor - recipientExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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