The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial (NCT03307356) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
United States10 participantsStarted 2018-01-10
Plain-language summary
Options for childbearing are limited for the thousands of women in the United States who suffer from absolute uterine factor infertility. Uterine transplantation is an emerging treatment that provides hope for these individuals.
In the Penn UNTIL trial, the investigators plan to perform uterus transplants on five women who will ultimately undergo embryo transfer, pregnancy, delivery, and then transplant hysterectomy.
This trial is accepting women in need of a transplant and also women who are interested in being a live donor.
For more information please visit: https://clinicalresearch.itmat.upenn.edu/clinicaltrial/4821/congenital-abnormalitiesfemale-infertility-penn-ut/
Who can participate
Age range
21 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) a
. Age 21-40
. Lives in Philadelphia region for the duration of the trial
. Received counseling regarding alternatives to uterine transplant such as adoption or surrogacy
. Intact ovaries
. Vaginal length \>6 cm (average vaginal length established with dilators)
. Body mass index \<35 kg/m2
. Fluent in the English Language
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recipient: Successful engraftment of deceased or living donor uterus
Timeframe: Assessed 6 months after transplant
2
Recipient: Live-born child per embryo transfer
Timeframe: Assessed up to 35 weeks post-embryo transfer
. Previous multiple major abdominal/pelvic surgery
. Severe endometriosis
. History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
. History of prior malignancy except for cervical cancer in stage 1a or 1b (must be in remission for 3 years)
. History of significant psychiatric illness
. Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
. Allergy, hypersensitivity, or intolerance of heparin or aspirin
. Presence of active documented systemic infection or recent systemic infection within the past 3 months