NCT05646992

Uterus Transplantation to Treat Infertility

OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a prospective clinical cohort study to establish temporary allogenic uterus transplantation as a feasible and effective reconstructive strategy for the treatment of uterine factor infertility. Suitable candidates will proceed through as many as nine study stages: * Stage 1: Telephone Screening Interview * Stage 2: Blood Work Screening * Stage 3: In Vitro Fertilization (IVF) \& Embryo Cryopreservation * Stage 4: Full Screening * Stage 5: Transplantation * Stage 6: Embryo Transfer * Stage 7: Pregnancy to Childbirth * Stage 8: Uterus Explantation * Stage 9: Longitudinal Follow-Up Potential participants will first be screened by phone for general eligibility, motivations for transplantation, and probable identification of a living donor. Potential donors will be interviewed by an Independent Living Donor Advocate to determine eligibility. Suitable candidates and candidates' potential living donors will then undergo blood work screening to determine if it's an acceptable pairing for donation and transplantation. Next, if the recipient does not already have embryos banked at a Johns Hopkins Hospital facility, she will participate in IVF and embryo cryopreservation per standard of care protocols. After a sufficient number of fertilized embryos have been successfully stored, the participant and her living donor will undergo full study screening. Donor/recipient pairs deemed suitable for transplantation based on screening results will be scheduled for and undergo transplant surgery. Post-uterus donation, the donor will be followed according to post-hysterectomy surgery patient care protocols. Post transplantation, the recipient will continue under the care of the study team as a transplant patient as well as under the care of gynecologists, obstetricians, and maternal fetal medicine experts. Depending on the transplant recipient's post-operative course, embryo transfer may be attempted as early as 2 months post-transplant. Should the patient become pregnant, obstetrics will follow the participant's and her fetus' progress. Whether or not the recipient successfully carries a pregnancy or births a child, uterus explantation is an anticipated endpoint of this protocol. Patients will be counseled that participants may have the transplant to birth up to two offspring or for about five years, whichever comes first, after which removal of the uterus should be considered. Study data on uterus transplant recipients will be collected for 5 years post-transplantation under this protocol, or for the entire time the participant has the graft, plus five years post-explantation. All attempts will be made to collect data on the offspring born as a result of this protocol through the offspring's 21st birthday.

Conditions

• Uterine Factor Infertility

Interventions

Type	Name	Description
PROCEDURE	Uterine Allotransplantation	Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.
DRUG	Tacrolimus	Used as daily immunosuppression. Started at 3mg twice daily (PO) on post-operative Day 1, adjusted to achieve serum trough concentrations of 8-10ng/ml.
DRUG	Imuran	Used as daily immunosuppresion. 100 mg for total body weight less than 75 kg and 150 mg for total body weight greater than or equal to 75 mgs

Timeline

• Start date: 2023-03-01
• Primary completion: 2033-02-28
• Completion: 2043-02-28
• First posted: 2022-12-12
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States