Mayer Rokitansky Kuster Hauser Syndrome
Conditions
Brief 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
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)
Interventions
PROCEDUREUterine transplantation
Uterine transplantation from living donor
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 3 years | Obtaining of a pregnancy after uterine transplantation from a living donor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Rejection assessment | 5 years | Donor-specific antobodies monitoring |
| Safety assessment of the donor, the recipient and the fœtus | 7 years | Monitoring of all the Adverse events |
| Psychological assessment of the donor and the recipient | 7 years | Psychological consequences linked to the procedure determined by repeated interviews with psychologists |
Countries
France
Outcome results
None listed