NCT03581019

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

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 not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 17, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 17, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

3.5 years

First QC Date

June 17, 2018

Last Update Submit

June 20, 2024

Conditions

Absolute Uterine Factor InfertilityTransplantationMrk Anomaly

Keywords

infertility, uterus, transplantation, MRKH

Outcome Measures

Primary Outcomes (1)

  • birth of healthy child

    1-5 years after transplantation

Study Arms (1)

Uterus transplantation

EXPERIMENTAL

Uterus transplantation

Procedure: uterus transplantation

Interventions

uterus transplantationPROCEDURE

uterus transplantation from deceased donor

Uterus transplantation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Mats Brännström

Gothenburg, SE-41345, Sweden

Location

MeSH Terms

Conditions

Mullerian aplasiaInfertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mats Brännström

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Observational study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2018

First Posted

July 10, 2018

Study Start

June 17, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

SE(2)