Uterus Transplantation From a Multi-organ Donor

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

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

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female; Mayer Rokitansky Kuster Hauser Syndrome
• Intervention / Treatment: Procedure: uterus transplantation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Weyers, MD, PhD; Phone Number: +3293325446; Email: steven.weyers@uzgent.be
• Study Contact Backup: Name: Sara Somers, MSc; Phone Number: +3293323757; Email: Sara.Somers@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital - Women's Clinic
    • Contact: Phone Number: +3293322117; Email: baarmoedertransplantatie@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uterus transplantation	Procedure: uterus transplantation; transplantation of a uterus from a deceased donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the uterus 1 year after transplantation	Survival of the uterus 1 year after transplantation	1 year after uterus transplantation
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)
Ongoing pregnancy rate	Ongoing pregnancy rate	4 weeks after embryo transfer
Take home baby rate	Take home baby rate	9 months after embryo transfer

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Infertility, female; Mayer Rokitansky Kuster Hauser Syndrome; Transplantation; Deceased donor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female; 46, XX Disorders of Sex Development
• Other Study ID Numbers: EC/2016/0731

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No