Uterus Transplantation to Treat Infertility (NCT05646992)
OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility
🩺 Plain-English Summary (8th-Grade Level)
This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years. The goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed. Transplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery. Study Duration: * Uterus Donors: Screening through about 12 months following the transplant operation. * Uterus Recipients: Recipients may have the uterus for about 5 years. After the transplant is removed, the study team will ask for yearly follow-ups for another 5 years. * Children born from transplanted uteruses: The study team asks to follow offspring yearly through age 21 years.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (23 items).
Location: Johns Hopkins University School of Medicine — Baltimore, Maryland
Age range: 18 Years to 38 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- EXCLUSION CRITERIA- Donor and Recipient Exclusion Criteria:
- Positive for any of the following conditions:
- Insulin-dependent diabetes mellitus.
- Untreated sepsis.
- HIV (active or seropositive).
- Active tuberculosis.
- Active Hepatitis B infection.
- Active Hepatitis C infection.
- Viral encephalitis.
- Toxoplasmosis.
- Current/recent (within 3 months of donation/screening consent) IV drug abuse.
- Significant cardiac disease
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Johns Hopkins University School of Medicine — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (410) 955-6875
Email: jlittl38@jhmi.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Uterine Factor Infertility clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.