Penn Medicine's Uterus Transplantation for Uterine Factor Infertility (UNTIL) trial is the first of its kind in the Northeastern United States. The trial began in 2017 as a joint effort between the Penn Transplant Institute and the Department of Obstetrics and Gynecology.
The UNTIL trial reached a major milestone in November 2019, when it welcomed the first baby born as part of the trial. The baby is the second child in the nation to be born following transplantation of a uterus from a deceased donor
Uterus transplantation provides a promising potential treatment for women with Uterine Factor Infertility (UFI) a previously irreversible form of female infertility that affects hundreds of thousands of reproductive-aged women in the U.S. A woman with UFI cannot carry a pregnancy. She is either born without a uterus, had her uterus removed, or has a nonfunctioning uterus. A uterus transplant has the potential to give women with UFI an opportunity to carry and deliver a child.
Many other programs around the globe have focused on transplantation exclusively from living donors, and to date, there have been approximately 70 uterus transplants globally. However, Penn Medicine’s trial is one of few to explore donation from both living or deceased donors — an approach that has the potential to expand the pool of organs available for donation and allows investigators the opportunity to directly compare outcomes from the different types of donors.
The UNTIL trial is currently the only U.S. uterus transplant trial that is actively enrolling patients. The strength of Penn's research program and exceptional quality of care, particularly in transplant and women's health, makes us uniquely positioned to be a leading clinical research program for uterus transplants in the United States.
The Uterus Transplant Process
Uterus transplantation involves both surgical and medical components. Participants in the trial will move through three phases.
A New Path to Parenthood: The first of its kind clinical trial in the Northeast, Penn Medicine's multi-year Uterine Factor Infertility (UNTIL) trial will provide uterus transplants to women with Uterine Factor Infertility
Pre-Uterus Transplant
After screening and enrollment, participants will undergo in vitro fertilization (IVF), during which their eggs are harvested and fertilized to create embryos that are then cryopreserved for transfer into the uterus following transplantation.
Uterus Transplant
Participants will go through a careful medical evaluation before they are listed for transplant with the United Network for Organ Sharing (UNOS).
The transplanted uterus can come from a deceased donor or a living donor. A living uterus donor gives her uterus for the purpose of transplantation to a female recipient. A deceased uterus donor is a female that is willing to donate her uterus after death.
Post-Uterus Transplant
After transplant surgery, participants will begin a regimen of immunosuppressant medications. These medications prevent immune rejection of the uterus and are identical to those taken by recipients of other types of organ transplants.
Once the participant heals, a single embryo will be placed into the uterus. The transfer will occur approximately 6 to 12 months after transplant, depending on the medical stability of the participant and the health of the uterus transplant.
If the participant becomes pregnant, she will be monitored closely by a team of obstetricians who specialize in high-risk pregnancies. The baby will be delivered via cesarean section at approximately 37 to 39 weeks (or earlier if needed for the health of the mother and/or baby).
Participants may have up to two children during the trial. Then surgeons will remove the uterus (a hysterectomy) and stop the immunosuppression.
The average length of participation in the trial for any given individual is expected to be approximately five years.
Interested in Uterus Transplant?
To learn more, please contact Dan Zhao, RN, MNHP at dan.zhao@uphs.upenn.edu or 215-615-5162. Or, if you are interested in receiving a uterus transplant or donating your uterus, complete the online consent form and someone will contact you.