Ovarian Tissue Transplantation for Premature Ovarian Failure

Overseen By Kylie Phillips

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rebecca Flyckt

No Placebo Group

Trial Summary

What is the purpose of this trial?

Premature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is typically made based on high levels of follicle stimulating hormone (FSH) and absent or irregular menstrual periods. It leads to infertility and menopause-like effects (hot flashes and thin bones) due to low estrogen levels. POI can result from various factors such as genetic conditions, autoimmune diseases, or previous medical treatments like chemotherapy. Treatment of POI usually involves hormone replacement therapy and, if pregnancy is desired, assisted reproductive technologies such as in vitro fertilization (IVF) using an egg donor. However, IVF may not be an option for everyone due to personal, religious, ethical or financial reasons. Recent advances in medicine have identified ovarian tissue transplantation (OTT) as a potential solution. OTT involves transplanting either fresh or frozen ovarian tissue into the pelvic area, where it can begin functioning again. Studies in animals and humans have shown success in restoring hormonal function and even achieving pregnancies in some cases. Initial human trials of ovarian tissue transplants from another individual began with identical twins and have since expanded to include non-identical siblings with compatible tissue matches using immunosuppression. Success rates of OTT have been promising, with multiple live births reported between identical twins. Long-term studies indicate that transplanted tissue can remain functional for up to eight years. Ovarian tissue transplantation offers a promising avenue for women with POI to help restore fertility and hormonal function. Continued research and refinement of tissue techniques are essential to improve outcomes and expand access to this innovative treatment option. This study will enroll 10 participants who will undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol at University Hospitals.

Research Team

Kathryn Coyne, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Rebecca Flyckt, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for women under 40 with premature ovarian failure, leading to infertility and menopause-like symptoms. Participants should have high FSH levels and irregular periods. They must have a non-identical sister willing to donate ovarian tissue and agree to use immunosuppression.

Inclusion Criteria

I am willing to try for a natural pregnancy within 4 months after my transplant.

I am willing to undergo surgery and anesthesia, including for high-risk pregnancy.

If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test

Exclusion Criteria

I have a history of high blood pressure, diabetes, or major organ disease. My creatinine level is above 1.0 mg/dL.

I have a history of HIV, mycobacteria, or hepatitis C.

Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history

Treatment Details

Interventions

• Ovarian Tissue Allo-transplantation (Procedure)

Trial Overview The study tests ovarian tissue transplantation in women with premature ovarian insufficiency. It involves transplanting tissue from a compatible sister into the patient's pelvic area, aiming to restore hormonal function and fertility.

Participant Groups

Group I: Ovarian tissue recipient Experimental Treatment 1 Intervention

Any recipient that receives ovarian tissue transplantation

Who Is Running the Clinical Trial?

Rebecca Flyckt

Lead Sponsor

Trials

1

Recruited

10+