Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT06673004
Eligibility Criteria:
Recipient Inclusion Criteria:
* 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 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.
Recipient Exclusion Criteria:
* 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.
* Chemical and/or alcohol dependency or abuse.
* BMI greater than 30 kg/m2
* Prior organ transplant with rejection, infection, or graft thrombosis.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT06673004
Study Brief:
Protocol Section:
NCT06673004