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Uterus Transplantation From a Multi-organ Donor

Primary Purpose

Infertility, Female, Mayer Rokitansky Kuster Hauser Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
uterus transplantation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Infertility, female, Mayer Rokitansky Kuster Hauser Syndrome, Transplantation; Deceased donor

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Ghent University Hospital - Women's ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterus transplantation

Arm Description

Outcomes

Primary Outcome Measures

Survival of the uterus 1 year after transplantation
Survival of the uterus 1 year after transplantation
Complications after uterus transplantation
Complications after uterus transplantation
Ongoing pregnancy rate
Ongoing pregnancy rate
Take home baby rate
Take home baby rate

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
December 9, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03252795
Brief Title
Uterus Transplantation From a Multi-organ Donor
Official Title
Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Mayer Rokitansky Kuster Hauser Syndrome
Keywords
Infertility, female, Mayer Rokitansky Kuster Hauser Syndrome, Transplantation; Deceased donor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uterus transplantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
uterus transplantation
Intervention Description
transplantation of a uterus from a deceased donor
Primary Outcome Measure Information:
Title
Survival of the uterus 1 year after transplantation
Description
Survival of the uterus 1 year after transplantation
Time Frame
1 year after uterus transplantation
Title
Complications after uterus transplantation
Description
Complications after uterus transplantation
Time Frame
As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
Title
Ongoing pregnancy rate
Description
Ongoing pregnancy rate
Time Frame
4 weeks after embryo transfer
Title
Take home baby rate
Description
Take home baby rate
Time Frame
9 months after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Weyers, MD, PhD
Phone
+3293325446
Email
steven.weyers@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Somers, MSc
Phone
+3293323757
Email
Sara.Somers@uzgent.be
Facility Information:
Facility Name
Ghent University Hospital - Women's Clinic
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3293322117
Email
baarmoedertransplantatie@uzgent.be

12. IPD Sharing Statement

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Uterus Transplantation From a Multi-organ Donor

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