An interventional study of Uterus transplantation in Primary Uterine Infertility, sponsored by Amro M. Hetta, M.Sc.. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Amro M. Hetta, M.Sc. · Not applicable, Interventional, and Treatment
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.
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).
Exclusion Criteria:
Patients undergo transplantation of the uterus from a live donor
Procedure: Uterus transplantation
Transplantation of the uterus from a live donor and IVF treatment
Also known as: UTx
Surviving transplants (8-12 months)
Follow up
Time frame: Up to 3 years after transplantation
Spontaneous menstruation commencement
Observation
Time frame: Up to 3 months after transplantation
Pregnancy rate
IVF treatment
Time frame: Up to 3 years after transplantation
Live birth rate
IVF treatment
Time frame: Up to 4 years after transplantation
Plan to share: Yes — Scientific publications and Prospective thesis of MD Degree
Supporting information: Study protocol, Sap, Icf
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.