Living Donor Uterus Transplantation Between Identical Twins | NCT03138226

Studies
Living Donor Uterus Transplantation Between Identical Twins

NCT03138226

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 15, 2021Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Absolute Uterine Factor Infertility
Cervical Cancer

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

Dec 2021

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

Jan 1, 2017Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Apr 30, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 3, 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

Dec 14, 2021

Last Update Posted Date

Dec 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mats Brännström, Professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Name	Class
University Hospital Tuebingen	OTHER
University of Belgrade	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Detailed Description

Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1Actual

Name	Type	Description	Arm Group Labels	Other Names
uterus transplantation	Procedure

Measure	Description	Time Frame
Live births after uterus transplantation		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age below 40 years
absolute uterine factor infertility
BMI<30-

Exclusion Criteria:

systemic disease

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

absolute uterine factor infertility - monozygotic twin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Published in articles

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D007246	Infertility

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

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Browse Branches

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