NCT03590405

Brief Summary

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

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

Study Start

First participant enrolled

June 15, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
3.4 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

3.5 years

First QC Date

June 17, 2018

Last Update Submit

December 14, 2021

Conditions

Mrk AnomalyInfertility, Female

Keywords

uterusinfertilitytransplantation

Outcome Measures

Primary Outcomes (1)

  • live birth

    live birth

    3 years

Study Arms (1)

uterus transplantation

EXPERIMENTAL

uterus transplantation from living donor with the donor being close relative

Procedure: uterus transplantation surgery and IVF

Interventions

uterus transplantation surgery and IVFPROCEDURE

IVF before surgery living donor uterus transplantation ET

uterus transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age \< 38 years
  • psychologicaly stable
  • BMI \< 35
  • no systemic disease
  • no standing medication
  • in a stable relationship or married
  • normal ovarian reserve
  • absolute uterine factor infertility
  • normal kidney function
  • close relative to recipient
  • age \< 60 years
  • normal pregnancies
  • maximum two cesarean sections
  • BMI \< 35
  • no major 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, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Mats Brännström, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 17, 2018

First Posted

July 18, 2018

Study Start

June 15, 2018

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

Locations

SE(2)