RecruitingNot Applicable

Uterus Transplantation From a Multi-organ Donor

Belgium20 participantsStarted 2016-11-03

Plain-language summary

Uterus transplantation: screening, in vitro fertilization \[IVF\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.

Who can participate

Age range

18 Years – 38 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: * Female with Maier-Rokitansky-Kuster-Hauser syndrome * Mucosal neovagina of at least 7 cm * In a stable relationship for at least 1 year * Child wish * Good renal function (and presence of both kidneys) * Psychologically stable and compliant * At least 8 frozen embryos after IVF/intracytoplasmic sperm injection \[ICSI\] * Living in Belgium and a good health insurance * Willing and able to provide informed consent Exclusion Criteria: * Major pelvic surgery * Major chronic illnesses * Other risk factors or malignancies * BMI \> 30

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.

What they're measuring

Survival of the uterus 1 year after transplantation

Timeframe: 1 year after uterus transplantation

Complications after uterus transplantation

Timeframe: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)

Ongoing pregnancy rate

Timeframe: 4 weeks after embryo transfer

Take home baby rate

Timeframe: 9 months after embryo transfer

Trial details

NCT IDNCT03252795

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Steven Weyers, MD, PhD

+3293325446 steven.weyers@uzgent.be

View on ClinicalTrials.gov More Infertility, Female trials