Feasibility Study of Uterine Transplantation From Living Donors in Terms of Efficacy and Safety i… (NCT03689842) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
FEMALE
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.