RecruitingNot ApplicableNCT03689842
Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
Sponsor
Hopital Foch
Enrollment
20 participants
Start Date
Dec 14, 2017
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years
Inclusion Criteria7
- 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 Criteria6
- 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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Interventions
PROCEDUREUterine transplantation
Uterine transplantation from living donor
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03689842