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Uterus Transplantation From Deceased Donor - Gothenburg III

Primary Purpose

Absolute Uterine Factor Infertility, Transplantation, Mrk Anomaly

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
uterus transplantation
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Absolute Uterine Factor Infertility focused on measuring infertility, uterus, transplantation, MRKH

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital
  • Mats Brännström

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterus transplantation

Arm Description

Uterus transplantation

Outcomes

Primary Outcome Measures

birth of healthy child

Secondary Outcome Measures

Full Information

First Posted
June 17, 2018
Last Updated
December 14, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03581019
Brief Title
Uterus Transplantation From Deceased Donor - Gothenburg III
Official Title
Uterus Transplantation From Deceased Donor - Gothenburg III
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 17, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Absolute Uterine Factor Infertility, Transplantation, Mrk Anomaly
Keywords
infertility, uterus, transplantation, MRKH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uterus transplantation
Arm Type
Experimental
Arm Description
Uterus transplantation
Intervention Type
Procedure
Intervention Name(s)
uterus transplantation
Intervention Description
uterus transplantation from deceased donor
Primary Outcome Measure Information:
Title
birth of healthy child
Time Frame
1-5 years after transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Brännström
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Mats Brännström
City
Göteborg
ZIP/Postal Code
SE-41345
Country
Sweden

12. IPD Sharing Statement

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Uterus Transplantation From Deceased Donor - Gothenburg III

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