NCT03138226

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

4.9 years

First QC Date

April 30, 2017

Last Update Submit

December 14, 2021

Conditions

Absolute Uterine Factor InfertilityCervical Cancer

Keywords

uterus, transplantation, infertility, twin

Outcome Measures

Primary Outcomes (1)

  • Live births after uterus transplantation

    5 years

Interventions

uterus transplantationPROCEDURE

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

absolute uterine factor infertility - monozygotic twin

You may qualify if:

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

You may not qualify if:

  • systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical biopsies

MeSH Terms

Conditions

Uterine Cervical NeoplasmsInfertility

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 3, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 15, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Published in articles

Locations

SE(1)