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NCT03252795 Clinical Trial

Uterus Transplantation From a Multi-organ Donor

Infertility, Female Clinical Trial

Official title:
Uterus Transplantation From a Multi-organ Donor: A Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03252795
Other study ID # EC/2016/0731
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2016
Est. completion date December 31, 2027

Study information
Verified date February 2024
Source University Hospital, Ghent
Contact Steven Weyers, MD, PhD
Phone +3293325446
Email steven.weyers@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• uterus transplantation
transplantation of a uterus from a deceased donor

Locations
Country Name City State
Belgium Ghent University Hospital - Women's Clinic Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival of the uterus 1 year after transplantation Survival of the uterus 1 year after transplantation 1 year after uterus transplantation
Primary Complications after uterus transplantation Complications after uterus transplantation As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
Primary Ongoing pregnancy rate Ongoing pregnancy rate 4 weeks after embryo transfer
Primary Take home baby rate Take home baby rate 9 months after embryo transfer
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