Uterus Transplantation to Treat Infertility

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.