The University of Pennsylvania Health System (Penn Medicine) has initiated a clinical trial of uterine transplantation for the irreversible uterine factor infertility (UFI) in the US.
Uterine transplantation is said to be a complex procedure involving surgical and medical components. The investigators plan to use organs from deceased donors aged 21-40 years who have successfully delivered healthy children.
The Uterine Transplantation for Uterine Factor Infertility (UNTIL) trial aims to help women with UFI as they cannot carry a pregnancy due to the absence, surgical removal or presence of an improperly functioning uterus.
Including specialists in transplant, obstetrics and gynaecology, clinical trials, bioethics, nursing, social work, psychology, pathology and infectious diseases, UNTIL will comprise extensive evaluation and follow-up of the trial subjects for several years.
Over the duration of five to ten years, each participant will be monitored by more than 35 providers.
The trial’s pre-transplant phase includes screening, enrolment and in-vitro fertilisation (IVF), during which eggs are harvested and fertilised to create embryos for transfer into the uterus after transplantation.
The transplant phase will include the surgery, followed by use of standard immunosuppressant medicines to prevent transplant rejection and monitoring for one year to assess the psychological, social and physical well-being of the participants.
Upon healing and healthy functioning of the uterus, a single embryo will be placed into the organ during the post-transplant phase of the trial.
UNTIL trial co-principal investigator Eileen Wang said: “In most cases, the absence of a uterus also means these women likely do not have a ‘normal’ vaginal canal, making it risky, or impossible, for them to have a vaginal delivery.
“However, our team of experts is taking every precaution to ensure the health and safety of both our mothers and babies.”
Following delivery of two healthy babies, the transplanted uterus will be removed through a hysterectomy.
To date, more than 30 uterine transplants have been performed across countries such as Brazil, China, the Czech Republic, Germany, Sweden, India, Saudi Arabia, Turkey, and the US.