First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Amro M. Hetta, M.Sc.

Status: Unknown

Conditions: Primary Uterine Infertility

Treatments: Procedure: Uterus transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03284073

OG4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 11 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than 45 years old
• Good general health

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Uterus Transplantation

Experimental group

Description:

Patients undergo transplantation of the uterus from a live donor

Treatment:

Procedure: Uterus transplantation