Ovarian Tissue Allo-transplantation

Inclusion criteria

(Donor):

• Must meet criteria for ovarian sufficiency: Menstruating; Premenopausal serum hormone (FSH, LH, estradiol, AMH) levels
• Must be between the ages of 21-35 years old.
• Must be genetic sister to recipient participant, which will be assessed by patient report.
• Must have history of at least one healthy live birth.
• Must have more than one ovary (i.e. must have both the left and right ovary).
• Must be willing to undergo a donor transplant evaluation including serologies and nucleic acid testing (NAT, which is essentially rapid PCR) for infectious conditions.
• Must have normal female karyotype (46,XX).
• Must have negative testing for HIV type 1 and 2, Hepatitis B, Hepatitis C, syphilis, West Nile Virus, gonorrhea and chlamydia.
• Must be willing to undergo general anesthesia, minimally invasive gynecologic surgery, and loss of unilateral ovary.
• If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test.
• Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol.
• Donors (with their marital partners, when applicable) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements.

Inclusion criteria

(Recipient):

• Must meet criteria for primary ovarian insufficiency: Amenorrheic x12 months; Serum hormone (FSH, LH, estradiol, AMH) levels consistent with menopause
• Must be between the ages of 21-40 years old.
• Must be in a committed relationship with a male partner.
• Must be willing to attempt natural conception within 4 months following transplant.
• Must be willing to undergo a pre-transplant evaluation.
• Must be willing to undergo Maternal Fetal Medicine consultation and evaluation for safety of pregnancy, particularly patients at risk of complications in pregnancy (e.g. Turner syndrome patients).
• Must be willing to undergo general anesthesia, minimally invasive gynecologic surgery, pregnancy with potential high risk complications, and surgery to remove the graft
• Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
• Must have been offered and declined donor oocyte IVF as a first line treatment option
• Must be willing to receive standard vaccinations such as influenza, Hepatitis B. If age and circumstances indicate, be willing to receive vaccines against pneumococcus, HPV and Hepatitis A.
• If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test.
• Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol, including assent for monitoring neonatal outcomes for the first year after birth.
• Intended parents (meaning, the recipient and partner) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements.

Inclusion criteria

(Recipient Male Partner)

• Must be age 18 years or older (and a combined age not greater than 110 years).
• Must have a normal semen analysis.
• Must be willing and able to sign informed consent.
• Intended parents (meaning, the recipient and partner) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements.

Exclusion criteria

(Donor) (to be verified by history and review of the medical chart by the study team)

• History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease.
• Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history.
• Current smoker (smoking cessation must have occurred 3 months prior to enrollment).
• History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
• History of human immunodeficiency virus (HIV), mycobacteria, hepatitis C.
• Hepatitis B infection (Hepatitis B risk is for those with HepB surface antigen and/or HBV DNA positive. Those that are HepB core antibody true-positive are at minimal risk of reactivation. Those with vaccine-induced HepB surface antibody are not at risk).
• Presence of active documented systemic infection or recent systemic infection within the past three months: Positive for syphilis (T. pallidum), chlamydia (C. trachomatis) or gonorrhea (N. gonorrhea).
• BMI greater than 35 kg/m2

Exclusion criteria

(Recipient)

• History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease. Serum creatinine level >1.0 mg/dL.
• Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history.
• Current smoker (smoking cessation must have occurred 3 months prior to enrollment).
• Active HPV infection.
• History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
• History of human immunodeficiency virus (HIV), mycobacteria, hepatitis C.
• Hepatitis B infection (Hepatitis B risk is for those with HepB surface antigen and/or HBV DNA positive. Those that are HepB core antibody true-positive are at minimal risk of reactivation. Those with vaccine-induced HepB surface antibody are not at risk).
• Presence of active documented systemic infection or recent systemic infection within the past three months.
• Significant mental illness or substance abuse.
• BMI greater than 30 kg/m2
• Prior organ transplant with rejection, infection, or graft thrombosis.

Exclusion criteria

(Recipient Male Partner )

• Inability to complete regular intercourse.
• History of incarceration.
• Significant mental illness or substance abuse.