Ovarian Tissue Allo-transplantation for Ovarian Failure
This study is exploring a new treatment called ovarian tissue allo-transplantation for women with premature ovarian failure (also known as primary ovarian insufficiency or POI). POI causes infertility and menopause-like symptoms due to low estrogen. In this procedure, you would receive ovarian tissue from a donor. The goal is to see if this can restart your menstrual periods and lead to live births. The study plans to enroll 10 women, aged 21 to 40. Donors must be your genetic sister, 21-35 years old, have regular periods, healthy hormone levels, and have had at least one healthy live birth. The study's current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
- What's involved
- Participants will undergo a procedure to receive donor ovarian tissue and take medications to prevent rejection (immunosuppression).
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track if your periods resume for up to 6 months and the number of live births for up to 3 years.
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NCT06673004
Ovarian Tissue Allo-transplantation
Not Yet Recruiting
NAAges 21–40InterventionalTreatmentUniversity Hospitals Cleveland Medical CenterInvestigator-initiated
~10 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Ovarian tissue allo-transplantation
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time (days) from transplantation to resumption of menses as measured by patient report
Measured over Up to 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Rebecca Flyckt, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
- Kathryn Coyne, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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
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
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.
Inability to complete regular intercourse.
History of incarceration.
Significant mental illness or substance abuse.
What this trial measures
- Time (days) from transplantation to resumption of menses as measured by patient reportUp to 6 months
- Number of live births as measured by medical record report/patient reportUp to 3 years