Ovarian Tissue Allo-transplantation

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Rebecca Flyckt
Study ID
NCT06673004
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Ovarian tissue allo-transplantation — PROCEDURE
    Participants will receive donor ovarian tissue with immunosuppression

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 30, 2030
Completion
May 30, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ovarian tissue recipient
    Any recipient that receives ovarian tissue transplantation

Primary Outcome Measure

Time (days) from transplantation to resumption of menses as measured by patient report [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Kylie Phillips
[email protected]
216-286-0765

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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