Recruiting NCT03252795
Uterus Transplantation From a Multi-organ Donor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: uterus transplantation.
- Who it may be relevant to
- Registry conditions: Infertility, Female, Mayer Rokitansky Kuster Hauser Syndrome. Basic parameters: 18 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
Overview
Uterus transplantation: screening, in vitro fertilization \[IVF\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
Interventions
- Procedure uterus transplantation
transplantation of a uterus from a deceased donor
Primary outcome measures
- Survival of the uterus 1 year after transplantation [Time frame: 1 year after uterus transplantation]
- Complications after uterus transplantation [Time frame: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)]
- Ongoing pregnancy rate [Time frame: 4 weeks after embryo transfer]
- Take home baby rate [Time frame: 9 months after embryo transfer]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University Hospital - Women's Clinic — Ghent
Identifiers
NCT: NCT03252795 · EC/2016/0731