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NCT Number: NCT03252795

Uterus Transplantation From a Multi-organ Donor

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

Recruiting

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Mayer Rokitansky Kuster Hauser Syndrome Mullerian aplasia Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital - Women's Clinic

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

CONTACT

[email protected]

+3293322117

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uterus transplantation

Procedure

transplantation of a uterus from a deceased donor

Primary outcomes

  1. Survival of the uterus 1 year after transplantation

    Time frame: 1 year after uterus transplantation

    Survival of the uterus 1 year after transplantation

  2. Complications after uterus transplantation

    Time frame: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)

    Complications after uterus transplantation

  3. Ongoing pregnancy rate

    Time frame: 4 weeks after embryo transfer

    Ongoing pregnancy rate

  4. Take home baby rate

    Time frame: 9 months after embryo transfer

    Take home baby rate

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Somers, MSc

CONTACT

[email protected]

+3293323757

Steven Weyers, MD, PhD

CONTACT

[email protected]

+3293325446

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2017
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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