The UNTIL trial is focusing on performing uterus transplants on women diagnosed with uterine factor infertility (UFI). UFI is an irreversible form of female infertility that affects as many as 5% of women worldwide. A woman with UFI cannot carry a pregnancy. Either because she was born without a uterus, has had the uterus surgically removed, or has a uterus that does not function. In the UNTIL trial we will only be including patients who were born without a uterus or who had their uterus surgically removed. Gestational carriers (surrogates) and adoption are the only ways women with UFI can have children.

A woman between the ages of 30 and 50 years who is in good health overall, has had children and has completed her child bearing is eligible to be a living uterus donor.

A successful Swedish research team paved the way for the UNTIL study. After years of uterus transplant research, the Swedish team was able to successfully transplant a uterus from a living donor into a woman with UFI. As of October 2016, 9 uterus transplants had been performed in Sweden resulting in live births in 6 of the 9 women who participated in the study. As of September 2017, eight babies have been born in Sweden following uterus transplantation. Penn Medicine is one of three centers in the United States offering uterus transplant through an experimental protocol to women with UFI. The UNTIL trial will use a donor uterus from a living or deceased donor for transplantation. A living donor is an individual who has completed her childbearing and is willing to donate her uterus to a woman with uterine factor infertility. Deceased donors are individuals who die from accidents, medical conditions or other events, and either they or their next of kin consent to donating their organs to individuals in need. Two children have been born in the United States following uterus transplantation at Baylor University medical Center in Texas. One child was born following uterus transplantation in Brazil. As of January 2019, 14 babies have been born following uterus transplantation.

Candidates to receive a uterus transplant are women between the ages of 21 and 40 with UFI who live in or near the Philadelphia area (or are able to relocate to the area) for the duration of the study. Potential recipients will undergo an extensive evaluation by a team of physicians, psychologists, nurses and social workers – the evaluation is extensive since women will undergo multiple surgeries and in vitro fertilization (IVF) as part of this trial. Living donors will also undergo an extensive evaluation by a team of physicians, psychologists, nurses and social workers.

Following uterus transplant, women cannot become pregnant without assistance. Therefore, prior to receiving the uterus, embryos (the earliest stage of development for a baby) must be created through IVF. IVF requires stimulation of the woman’s ovaries to produce multiple eggs. This is followed by removal of the eggs and fertilization of the eggs with sperm in the IVF lab. Embryos that are created are frozen for later use. For more information on the IVF process, visit the Penn Fertility Care website.

Removal of the uterus (hysterectomy) for transplantation from both a living and deceased donor takes approximately 6-10 hours. The expected recovery time in the hospital for living donors undergoing hysterectomy is 4-5 days. Some patients will be discharged from the hospital with a catheter in place that drains urine from the bladder and is removed at a subsequent clinic visit. The cost of the evaluation, surgery and hospitalization will be covered by the UNTIL research trial. However, as is the case with donation of other organs, individuals will not be compensated for donating their uterus. After the donor’s uterus is removed along with its blood vessels, the recipient surgery can begin. The recipient surgery also takes 6-10 hours. The uterus is transplanted into the woman’s pelvis. The donor’s blood vessels are connected to her blood vessels. The expected recovery time in the hospital after surgery is 7-10 days.

Full recovery following hysterectomy for the purpose of uterus transplant can take up to 6 weeks. We require living donors to stay in the Philadelphia area following hysterectomy to ensure healing occurs and any complications are successfully managed. Donors will be followed by phone for up to two years following hysterectomy.

Recipients will be administered anti-rejection drugs for as long as they retain the uterus. After transplant, the recipient will need frequent blood tests, ultrasounds and tissue sampling and clinical visits to monitor for signs of rejection, infection and complications. Once the uterus heals and is functioning, with no infections or rejection episodes that could not be treated, a single embryo is put back into the uterus. When a pregnancy is achieved, the pregnancy is monitored closely by a team of high-risk obstetricians and the recipient will continue to take anti-rejection medications for the duration of the pregnancy. These medications may have effects on the developing baby. The baby will be delivered via C-section (about 37 weeks) or earlier if needed for the health of the mother and/or baby. After the recipient has delivered 1 or 2 healthy babies the uterus is removed and anti-rejection mediations are stopped.