Uterine transplantation from living donors for women with MRKH syndrome
Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety in Patients With Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
This study is testing if women with MRKH syndrome can successfully receive a uterus transplant from living donors to help them achieve pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Hopital Foch Academic / other |
| Locations | 1 site (Suresnes) |
| Trial ID | NCT03689842 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of uterine transplantation from living donors in women diagnosed with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, a condition characterized by the absence of a uterus. The trial will involve 10 patients who will receive a uterus transplant and will be monitored for both the anatomical and functional outcomes of the transplant, as well as the safety and psychological well-being of the living donors. The ultimate goal is to achieve a successful pregnancy following the transplantation procedure.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 38 with MRKH type I syndrome who are in stable relationships and have a desire for pregnancy.
Not a fit: Patients with severe male infertility issues or significant medical history that complicates surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable option for women with MRKH syndrome to achieve pregnancy.
How similar studies have performed: While uterine transplantation is a novel approach, there have been successful cases in other countries, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Suresnes
- Hopital Foch — Suresnes, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.