Uterus Transplantation to Treat Infertility

Launched by JOHNS HOPKINS UNIVERSITY · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring uterus transplantation as a way to help women who cannot become pregnant due to not having a uterus, a condition known as uterine factor infertility. The goal is to allow these women to experience pregnancy and give birth to their own children. In this study, women who want to donate their uterus will undergo surgery to provide it to a recipient. The recipient will take medication to help keep her body from rejecting the new uterus, but this medication can have side effects. The plan is for the transplanted uterus to be used for about five years, during which time the recipient can try to become pregnant and give birth, after which the uterus will be removed.

To participate in this study, women must be between 18 and 38 years old, have a strong desire to have children, and already have fertilized embryos stored at Johns Hopkins. They also need to find a donor who is a good match for them. Potential donors are women aged 25 to 65 who have had a successful pregnancy before. Both donors and recipients must meet specific health criteria to ensure a safe and successful transplant. The study will involve follow-ups for several years after the transplant to monitor the health of both the mother and any children born from the transplant.

Gender

FEMALE

Eligibility criteria

• • 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.
• • Willingness to undergo embryo implantation after uterus transplantation to achieve pregnancy.
• • In the opinion of the study team, makes a reasonable effort to identify and refer her own potential uterus donor to the study team.
• • Completes the protocol informed consent form.
• • Non-smoker, defined by having never smoked or having quit \>6 consecutive months prior to screening.
• • No co-existing medical condition which, in the opinion of the study team, could affect the immunosuppression protocol, surgical procedure, or ability to be pregnant or bear a child. (See Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of uterus transplantation.)
• • Negative serum pregnancy test.
• • Blood type compatible with donor.
• • Negative crossmatch with donor.
• • Patient agrees to comply with the protocol and states a dedication to the treatment regime.
• • Agrees to uterus explanation following birth of a child and or 5 years without successful pregnancy.
• Donor Inclusion Criteria:
• • Genotypic female with an intact uterus.
• • Medical history includes known successful pregnancy (e.g., gravid uterus).
• • Aged 25 - 65 years.
• • Consents to uterus donation and required pre-donation screening.
• • For females of child-bearing potential: Negative serum pregnancy test.
• • Blood type compatible with recipient.
• • Negative crossmatch with recipient.
• Donor and Recipient Inclusion Criteria:
• • USA citizen or equivalent.
• • No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
• • BMI ≤35
• • o A higher BMI may be accepted at the discretion of the study team.
• • Negative for HIV at transplant.
• • Negative for malignancy for past 5 years.
• • 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
• • Significant vascular disease o
• • Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.
• • Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
• • Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.
• • Severe neurologic deficits.
• • Patients considered unsuitable per the consulted Psychiatric/Psychologic appraisal.
• • A history of medical non-compliance.
• Donor Only Exclusion Criteria:
• • Previous injury to the uterus including giving birth by Cesarean section.
• • History of radiation therapy to the abdominal area.
• • Other medical conditions, as determined by the study physicians, that would preclude donation.
• Recipient Only Exclusion Criteria:
• • • Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.

Trial Officials