NCT03252795

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2016Dec 2027

Study Start

First participant enrolled

November 3, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

11.2 years

First QC Date

June 22, 2017

Last Update Submit

February 13, 2024

Conditions

Infertility, FemaleMayer Rokitansky Kuster Hauser Syndrome

Keywords

Infertility, femaleMayer Rokitansky Kuster Hauser SyndromeTransplantation; Deceased donor

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Uterus transplantation

EXPERIMENTAL
Procedure: uterus transplantation

Interventions

uterus transplantationPROCEDURE

transplantation of a uterus from a deceased donor

Uterus transplantation

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Major pelvic surgery
  • Major chronic illnesses
  • Other risk factors or malignancies
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital - Women's Clinic

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleMullerian aplasia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Steven Weyers, MD, PhD

CONTACT

+3293325446steven.weyers@uzgent.be

Sara Somers, MSc

CONTACT

+3293323757Sara.Somers@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

August 17, 2017

Study Start

November 3, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

BE(1)