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Uterus Transplantation From a Multi-organ Donor

G

Ghent University Hospital (UZ)

Status

Enrolling

Conditions

Mayer Rokitansky Kuster Hauser Syndrome
Infertility, Female

Treatments

Procedure: uterus transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03252795
EC/2016/0731

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 38 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Uterus transplantation
Experimental group
Treatment:
Procedure: uterus transplantation

Trial contacts and locations

1

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Central trial contact

Sara Somers, MSc; Steven Weyers, MD, PhD

Data sourced from clinicaltrials.gov

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