First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Study Overview
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Brief Summary
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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
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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).

Official Title
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First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Conditions
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Primary Uterine Infertility

Intervention / Treatment
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* Procedure: Uterus transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than 45 years old Good general health Exclusion Criteria: Older than 45 years old Poor ovarian reserve Systematic or psychiatric disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Human uterus transplantation from a live donor
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterus Transplantation<br>Patients undergo transplantation of the uterus from a live donor | Procedure: Uterus transplantation<br>* Transplantation of the uterus from a live donor and IVF treatment<br>* Other names: UTx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surviving transplants (8-12 months) | Follow up | Up to 3 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous menstruation commencement | Observation | Up to 3 months after transplantation | 
| Pregnancy rate | IVF treatment | Up to 3 years after transplantation | 
| Live birth rate | IVF treatment | Up to 4 years after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterus, transplantation, infertility