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Procedure
Ovarian Tissue Transplantation for Premature Ovarian Failure
N/A
Waitlist Available
Led By Kathryn Coyne, MD
Research Sponsored by Rebecca Flyckt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be in a committed relationship with a male partner
Must be willing to undergo a pre-transplant evaluation
Must not have
History of hypertension, diabetes, or significant heart, liver, kidney, or central nervous system disease. Serum creatinine level >1.0 mg/dL
History of human immunodeficiency virus (HIV), mycobacteria, hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will involve 10 women with premature ovarian failure who will receive ovarian tissue transplants from their non-identical sisters to potentially restore fertility and hormonal function. The goal is to investigate the effectiveness
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include complications from surgery, rejection of transplanted tissue despite immunosuppression, infection risks due to weakened immune response, and possible hormonal imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in a committed relationship with a man.
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I am willing to have an evaluation before a transplant.
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I have been diagnosed with primary ovarian insufficiency.
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I am between 21 and 40 years old.
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I am willing to take strong medications to suppress my immune system and can follow infection prevention guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of high blood pressure, diabetes, or major organ disease. My creatinine level is above 1.0 mg/dL.
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I have a history of HIV, mycobacteria, or hepatitis C.
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I have an active HPV infection.
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I had an organ transplant that was followed by rejection, infection, or clotting.
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I have not had a serious infection in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ovarian tissue recipientExperimental Treatment1 Intervention
Any recipient that receives ovarian tissue transplantation
Find a Location
Who is running the clinical trial?
Rebecca FlycktLead Sponsor
Kathryn Coyne, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Rebecca Flyckt, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center