Uterus Transplantation From a Multi-organ Donor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03252795
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Information provided by (Responsible Party):
University Hospital, Ghent

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

Condition or disease Intervention/treatment Phase
Infertility, Female Mayer Rokitansky Kuster Hauser Syndrome Procedure: uterus transplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Uterus transplantation Procedure: uterus transplantation
transplantation of a uterus from a deceased donor

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03252795

Contact: Steven Weyers, MD, PhD +3293325446
Contact: Sara Somers, MSc +3293323757

Ghent University Hospital - Women's Clinic Recruiting
Ghent, Belgium, 9000
Contact    +3293322117   
Sponsors and Collaborators
University Hospital, Ghent

Responsible Party: University Hospital, Ghent Identifier: NCT03252795     History of Changes
Other Study ID Numbers: EC/2016/0731
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Ghent:
Infertility, female
Mayer Rokitansky Kuster Hauser Syndrome
Transplantation; Deceased donor

Additional relevant MeSH terms:
Infertility, Female
46, XX Disorders of Sex Development
Genital Diseases, Male
Genital Diseases, Female
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases