First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Not Applicable

• Conditions: Primary Uterine Infertility
• Interventions: Procedure: Uterus transplantation

• Registration Number: NCT03284073
• Lead Sponsor: Amro M. Hetta, M.Sc.

Brief Summary

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) \[uterus absence (congenital and surgical), or an abnormality (anatomic and functional)\].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

Detailed Description

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) \[uterus absence (congenital and surgical), or an abnormality (anatomic and functional)\].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

The study protocol includes live-donor UTx (mother, relative, friend) into women with AUFI. The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted after 8-12 months have passed from transplantation. Two official approvals must be obtained before starting recruitment process; from both (Higher Committee of Human Organ Transplantation of Egyptian Ministry of Health and Population, and Al-Azhar University Council).

Study Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Study Start: 2021-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Less than 45 years old
• Good general health

Exclusion Criteria

• Older than 45 years old
• Poor ovarian reserve
• Systematic or psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uterus Transplantation	Uterus transplantation	Patients undergo transplantation of the uterus from a live donor

Primary Outcome Measures

Name	Time	Method
Surviving transplants (8-12 months)	Up to 3 years after transplantation	Follow up

Secondary Outcome Measures

Name	Time	Method
Spontaneous menstruation commencement	Up to 3 months after transplantation	Observation
Pregnancy rate	Up to 3 years after transplantation	IVF treatment
Live birth rate	Up to 4 years after transplantation	IVF treatment

Trial Locations

Locations (1)

Mansoura Urology and Nephrology Center; 🇪🇬 Mansoura, Al-Dakahliya, Egypt