Clinical trial NCT03284073: First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Official title: First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Uterine Infertility
Keywords: uterus
transplantation
infertility
Lead sponsor: Talkha Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Al-Azhar University
name: Mansoura University
First posted: 2017-09-15
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Human uterus transplantation from a live donor
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Less than 45 years old
* Good general health

Exclusion Criteria:

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

Primary outcomes:
measure: Surviving transplants (8-12 months)
timeFrame: Up to 3 years after transplantation
Secondary outcomes:
measure: Spontaneous menstruation commencement
timeFrame: Up to 3 months after transplantation
measure: Pregnancy rate
timeFrame: Up to 3 years after transplantation
measure: Live birth rate
timeFrame: Up to 4 years after transplantation
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology and Nephrology Center
state: Al-Dakahliya
Study officials:
affiliation: Al-Azhar University
name: Amro M. Hetta, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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