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NCT03590405 Clinical Trial

Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

Infertility, Female Clinical Trial

— GOT-BMC-UTx  

Official title:
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03590405
Other study ID # Sahlgrenska-BMC-UTx
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2018
Est. completion date December 1, 2021

Study information
Verified date December 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• uterus transplantation surgery and IVF
IVF before surgery living donor uterus transplantation ET

Locations
Country Name City State
Sweden Mats Brännström Göteborg
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (2)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Saint Joseph University, at Bellevue Medical Centre

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary live birth live birth 3 years
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