Sister's ovary tissue may restore fertility in early menopause
NCT ID NCT06673004
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests whether transplanting ovarian tissue from a sister can restore fertility and hormone production in women with premature ovarian failure (early menopause). Ten women will receive tissue from their non-identical sister, along with immunosuppressive drugs to prevent rejection. The goal is to see if periods return and if pregnancy is possible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ovarian tissue transplant
- What this could lead to
- If successful, this could offer a way for women with premature ovarian failure to restore fertility and hormone function without needing an egg donor.
- What could go wrong
- This is a very small, early study with only 10 participants. The transplant requires lifelong immunosuppression, which carries risks like infection and organ damage. Success is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (Donor): * Must meet criteria for ovarian sufficiency: Menstruating; Premenopausal serum hormone (FSH, LH, estradiol, AMH) levels * Must be between the ages of 21-35 years old. * Must be genetic sister to recipient participant, which will be assessed by patient report. * Must have history of at least one healthy live birth. * Must have more than one ovary (i.e. must have both the left and right ovary). * Must be willing to undergo a donor transplant evaluation including serologies and nucleic acid testing (NAT, which is essentially rapid PCR) for infectious conditions. * Must have normal female karyotype (46,XX). * Must have negative testing for HIV type 1 and 2, Hepatitis B, Hepatitis C, syphilis, West Nile Virus, gonorrhea and chlamydia. * Must be willing to undergo general anesthesia, minimally invasive gynecologic surgery, and loss of unilateral ovary. * If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test. * Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol. * Donors (with their marital partners, when applicable) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements. Inclusion Criteria (Recipient): * Must meet criteria for primary ovarian insufficiency: Amenorrheic x12 months; Serum hormone (FSH, LH, estradiol, AMH) levels consistent with menopause * Must be between the ages of 21-40 years old. * Must be in a committed relationship with a male partner. * Must be willing to attempt natural conception within 4 months following transplant. * Must be willing to undergo a pre-transplant evaluation. * Must be willing to undergo Maternal Fetal Medicine consultation and evaluation for safety of pregnancy, particularly patients at risk of complications in pregnancy (e.g. Turner syndrome patients). * Must be willing to undergo general anesthesia, minimally invasive gynecologic surgery, pregnancy with potential high risk complications, and surgery to remove the graft * Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols * Must have been offered and declined donor oocyte IVF as a first line treatment option * Must be willing to receive standard vaccinations such as influenza, Hepatitis B. If age and circumstances indicate, be willing to receive vaccines against pneumococcus, HPV and Hepatitis A. * If patient is a smoker, 3 months cessation is required prior to enrollment and must pass a nicotine test. * Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol, including assent for monitoring neonatal outcomes for the first year after birth. * Intended parents (meaning, the recipient and partner) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements. Inclusion Criteria (Recipient Male Partner) * Must be age 18 years or older (and a combined age not greater than 110 years). * Must have a normal semen analysis. * Must be willing and able to sign informed consent. * Intended parents (meaning, the recipient and partner) must be willing to seek independent legal advice from attorneys with specific expertise in third-party reproduction to determine their legal rights and duties in entering into a donor reproductive tissue arrangements. Exclusion Criteria (Donor) (to be verified by history and review of the medical chart by the study team) * History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease. * Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history. * Current smoker (smoking cessation must have occurred 3 months prior to enrollment). * History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years. * History of human immunodeficiency virus (HIV), mycobacteria, hepatitis C. * Hepatitis B infection (Hepatitis B risk is for those with HepB surface antigen and/or HBV DNA positive. Those that are HepB core antibody true-positive are at minimal risk of reactivation. Those with vaccine-induced HepB surface antibody are not at risk). * Presence of active documented systemic infection or recent systemic infection within the past three months: Positive for syphilis (T. pallidum), chlamydia (C. trachomatis) or gonorrhea (N. gonorrhea). * BMI greater than 35 kg/m2 Exclusion Criteria (Recipient) * History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease. Serum creatinine level \>1.0 mg/dL. * Any medical diagnosis placing the subject at high risk of surgical complications based on the team's review of medical history. * Current smoker (smoking cessation must have occurred 3 months prior to enrollment). * Active HPV infection. * History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years. * History of human immunodeficiency virus (HIV), mycobacteria, hepatitis C. * Hepatitis B infection (Hepatitis B risk is for those with HepB surface antigen and/or HBV DNA positive. Those that are HepB core antibody true-positive are at minimal risk of reactivation. Those with vaccine-induced HepB surface antibody are not at risk). * Presence of active documented systemic infection or recent systemic infection within the past three months. * Significant mental illness or substance abuse. * BMI greater than 30 kg/m2 * Prior organ transplant with rejection, infection, or graft thrombosis. Exclusion Criteria (Recipient Male Partner ) * Inability to complete regular intercourse. * History of incarceration. * Significant mental illness or substance abuse.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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