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Clinical Trials in Belgium / NCT03252795
Recruiting Not applicable

Uterus Transplantation From a Multi-organ Donor

NCT03252795 · tracked via the Priya Life Science Belgium tracker
Sponsor
University Hospital, Ghent
Phase
Not applicable
Started
2016-11-03
Last updated
2024-02-14

Condition(s) studied

Infertility, FemaleMayer Rokitansky Kuster Hauser Syndrome

Investigational drug(s) / intervention(s)

uterus transplantation

uterus transplantation: transplantation of a uterus from a deceased donor

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
38 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Survival of the uterus 1 year after transplantation — 1 year after uterus transplantation
    Survival of the uterus 1 year after transplantation
  • 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
  • Ongoing pregnancy rate — 4 weeks after embryo transfer
    Ongoing pregnancy rate
  • Take home baby rate — 9 months after embryo transfer
    Take home baby rate

Trial sites (1)

FacilityCityRegionStatus
Ghent University Hospital - Women's Clinic Ghent Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03252795 on ClinicalTrials.gov ↗ ← All trials in Belgium