NCT03284073

First Clinical Live-Donor Uterus Transplantation Trial In Egypt

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (estimated)
• Sponsor: Amro M. Hetta, M.Sc. · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Primary Uterine Infertility

Interventions

Type	Name	Description
PROCEDURE	Uterus transplantation	Transplantation of the uterus from a live donor and IVF treatment

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-30
• Completion: 2022-10-31
• First posted: 2017-09-15
• Last updated: 2021-03-30

Locations

1 site across 1 country: Egypt