OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility
Johns Hopkins University
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.
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 Poten…
Eligibility
- Age range
- 18–38 years
- Sex
- Female
- Healthy volunteers
- Yes
INCLUSION CRITERIA - Recipient Inclusion Criteria: * Genotypic female of any race, color, or ethnicity. * Uterine factor infertility. * Aged 18-38 years at time of egg retrieval. * Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child. * Embryo cryopreservation with embryos located at Johns Hopkins: * Has a minimum of 4-8 cryopreserved normal embryos following Preimplantation Genetic Screening (PGS-screening). OR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos. * W…
Interventions
- ProcedureUterine Allotransplantation
Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.
- DrugTacrolimus
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.
- DrugImuran
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
Location
- Johns Hopkins University School of MedicineBaltimore, Maryland