Uterus Transplantation From a Multi-organ Donor
Not Applicable
Recruiting
- Conditions
- Infertility, FemaleMayer Rokitansky Kuster Hauser Syndrome
- Interventions
- Procedure: uterus transplantation
- Registration Number
- NCT03252795
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Uterus transplantation: screening, in vitro fertilization \[IVF\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Uterus transplantation uterus transplantation -
- Primary Outcome Measures
Name Time Method Survival of the uterus 1 year after transplantation 1 year after uterus transplantation Survival of the uterus 1 year after transplantation
Ongoing pregnancy rate 4 weeks after embryo transfer Ongoing pregnancy rate
Complications after uterus transplantation As long as the uterus remains in situ (the uterus will be removed within one year after delivery) Complications after uterus transplantation
Take home baby rate 9 months after embryo transfer Take home baby rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ghent University Hospital - Women's Clinic
🇧🇪Ghent, Belgium