Ovarian Tissue Transplantation for Premature Ovarian Failure
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take immunosuppressive medications and follow infection prevention protocols.
What data supports the effectiveness of the treatment Ovarian Tissue Allo-transplantation for Premature Ovarian Failure?
Research shows that ovarian tissue transplantation has led to successful restoration of ovarian function and even live births in some cases, such as the first live birth in China after this procedure. Additionally, studies in animals like olive baboons have shown that allogeneic ovarian transplantation can restore ovarian function, suggesting potential effectiveness in humans.12345
Is ovarian tissue transplantation safe for humans?
Ovarian tissue transplantation generally has a low risk of complications, similar to standard laparoscopy (a type of minimally invasive surgery). In a study of 1373 procedures, only three surgical complications were reported, and many women resumed menstruation and hormonal activity after the procedure.12467
How is ovarian tissue allo-transplantation different from other treatments for premature ovarian failure?
Ovarian tissue allo-transplantation is unique because it involves transplanting ovarian tissue from a donor to restore ovarian function, potentially offering an alternative to oocyte (egg) donation. This approach may use immunomodulators like preimplantation factor (PIF) to help the body accept the transplanted tissue without the need for extensive immune suppression.128910
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Transplantation
Participants undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol
Immunosuppression
Participants receive immunosuppression treatment to prevent rejection of the transplanted tissue
Follow-up
Participants are monitored for safety and effectiveness after transplantation
Treatment Details
Interventions
- Ovarian Tissue Allo-transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rebecca Flyckt
Lead Sponsor