Primary Uterine Infertility
Conditions
Keywords
uterus, transplantation, infertility
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).
Interventions
PROCEDUREUterus transplantation
Transplantation of the uterus from a live donor and IVF treatment
Sponsors
Al-Azhar University
Mansoura University
Amro M. Hetta, M.Sc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Human uterus transplantation from a live donor
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Less than 45 years old * Good general health
Exclusion criteria
* Older than 45 years old * Poor ovarian reserve * Systematic or psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surviving transplants (8-12 months) | Up to 3 years after transplantation | Follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | Up to 4 years after transplantation | IVF treatment |
| Pregnancy rate | Up to 3 years after transplantation | IVF treatment |
| Spontaneous menstruation commencement | Up to 3 months after transplantation | Observation |
Countries
Egypt
Contacts
Primary ContactAmro M. Hetta, M.Sc.
Outcome results
None listed