Uterus Transplantation From Deceased Donor - Gothenburg III | NCT03581019

Studies
Uterus Transplantation From Deceased Donor - Gothenburg III

NCT03581019

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Absolute Uterine Factor Infertility
Transplantation
Mrk Anomaly

Interventions

uterus transplantation

Countries

Sweden

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2018Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jun 17, 2018

First Submission Date that Met QC Criteria

Jul 6, 2018

First Posted Date

Jul 10, 2018Actual

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

Jun 20, 2024

Last Update Posted Date

Jun 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II

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

1Actual

Arms/Interventions Module

Arm Groups

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

Interventions

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

Measure	Description	Time Frame
birth of healthy child		1-5 years after transplantation

Eligibility Module

Eligibility Criteria

Inclusion criteria recipient

initially included with IVF and excluded by donor issues of Gothenburg I or II
initially included and excluded by early graft failure of Gothenburg I or II
age < 40 years
no systemic disease
no standing medication
satisfactory ovarian reserve
BMI <35 and at BMI 30-35 waist circumference of < 82 cm
absolute uterine factor infertility
psychological stable

Inclusion criteria donor

brain death and suitable as multiorgan donor
acceptance for donation of uterus from family or previously by patient
age <55 years
at least one normal pregnancy and childbirth
no previos malignancy
no systemic disease
no previous major surgery inn abdomen or on uterus

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mats Brännström	Göteborg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg		41345	Sweden
Mats Brännström

Condition Browse Module

MeSH Terms

ID	Term
C537371	Mullerian aplasia
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided