RecruitingNot Applicable

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

France20 participantsStarted 2017-12-14

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Pregnancy

Timeframe: 3 years

Trial details

NCT IDNCT03689842

SponsorHopital Foch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-14