Uterus Transplantation From a Multi-organ Donor | NCT03252795

Studies
Uterus Transplantation From a Multi-organ Donor

NCT03252795

Sponsor

University Hospital, Ghent

Status

Recruiting

Last Update Posted

Feb 14, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Infertility, Female
Mayer Rokitansky Kuster Hauser Syndrome

Interventions

uterus transplantation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2016Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jun 22, 2017

First Submission Date that Met QC Criteria

Aug 16, 2017

First Posted Date

Aug 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uterus transplantation	Experimental		Procedure: uterus transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uterus transplantation	Procedure	transplantation of a uterus from a deceased donor	Uterus transplantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Steven Weyers, MD, PhD	Contact	+3293325446		steven.weyers@uzgent.be
Sara Somers, MSc	Contact	+3293323757		Sara.Somers@uzgent.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital - Women's Clinic	Recruiting	Ghent		9000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female
C537371	Mullerian aplasia

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided