NCT06673004

Ovarian Tissue Allo-transplantation

Ovarian Tissue Allo-Transplantation in the Setting of Primary Ovarian Insufficiency Between Non-Genetically Identical Siblings With Use of Immunosuppression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Rebecca Flyckt · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Ovarian Failure
• Ovarian Insufficiency
• Menopause Ovarian Failure
• Menopause, Premature
• Infertility, Female
• Endocrine Female Infertility

Interventions

Type	Name	Description
PROCEDURE	Ovarian tissue allo-transplantation	Participants will receive donor ovarian tissue with immunosuppression

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-30
• Completion: 2030-05-30
• First posted: 2024-11-04
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States