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Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC (GOT-BMC-UTx)

Primary Purpose

Mrk Anomaly, Infertility, Female

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

About this trial

This is an interventional treatment trial for Mrk Anomaly focused on measuring uterus, infertility, transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria recipient

  • 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

Inclusion criteria donor

  • close relative to recipient
  • age < 60 years
  • normal pregnancies
  • maximum two cesarean sections
  • BMI < 35
  • no major systemic disease
  • no previous major surgery

Sites / Locations

  • Sahlgrenska University Hospital
  • Mats Brännström

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uterus transplantation

Arm Description

uterus transplantation from living donor with the donor being close relative

Outcomes

Primary Outcome Measures

live birth
live birth

Secondary Outcome Measures

Full Information

First Posted
June 17, 2018
Last Updated
December 14, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Saint Joseph University, at Bellevue Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03590405
Brief Title
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC
Acronym
GOT-BMC-UTx
Official Title
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Saint Joseph University, at Bellevue Medical Centre

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
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.
Detailed Description
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery. Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mrk Anomaly, Infertility, Female
Keywords
uterus, infertility, transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
uterus transplantation
Arm Type
Experimental
Arm Description
uterus transplantation from living donor with the donor being close relative
Intervention Type
Procedure
Intervention Name(s)
uterus transplantation surgery and IVF
Intervention Description
IVF before surgery living donor uterus transplantation ET
Primary Outcome Measure Information:
Title
live birth
Description
live birth
Time Frame
3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria recipient 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 Inclusion criteria donor close relative to recipient age < 60 years normal pregnancies maximum two cesarean sections BMI < 35 no major systemic disease no previous major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Brännström, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
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

Plan to Share IPD
No

Learn more about this trial

Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

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