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Sister's ovary tissue may restore fertility in early menopause

NCT ID NCT06673004

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

21 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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