Ovarian FailureNCT06673004
Ovarian Tissue Allo-transplantation
A study testing Ovarian tissue allo-transplantation in people with Ovarian Failure and Ovarian Insufficiency, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Failure, Ovarian Insufficiency, Menopause Ovarian Failure
- What is being tested?
- Ovarian tissue allo-transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- 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.
- 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
Who cannot join
- 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.
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- 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.
- Inability to complete regular intercourse.
- History of incarceration.
- Significant mental illness or substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Kylie Phillips, 216-286-0765, kylie.phillips@uhhospitals.org
About this study
Official title: Ovarian Tissue Allo-Transplantation in the Setting of Primary Ovarian Insufficiency Between Non-Genetically Identical Siblings With Use of Immunosuppression
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
- Being tested
- Ovarian tissue allo-transplantation
- Keywords
- Primary ovarian insufficiency, Ovarian tissue transplantation, Immunosuppression, Premature menopause, Ovarian failure, Ovary transplant
- Medical subject headings
- Menopause, Premature, Infertility, Female, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian tissue allo-transplantationProcedure or surgery
Participants will receive donor ovarian tissue with immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| Ovarian tissue recipient | Experimental | Any recipient that receives ovarian tissue transplantation Receives: Procedure: Ovarian tissue allo-transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) from transplantation to resumption of menses as measured by patient report
Measured: Up to 6 months
Number of live births as measured by medical record report/patient report
Measured: Up to 3 years
Secondary outcomes (1)
Time (days) from transplantation to pregnancy as measured by medical record/patient report
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Sep 2026 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Flyckt, MD, Principal investigator, University Hospitals Cleveland Medical CenterKathryn Coyne, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673004
- Sponsor's protocol ID
- STUDY20241094
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Allo-Transplantation in the Setting of Primary Ovarian Insufficiency Between Non-Genetically Identical Siblings With Use of Immunosuppression
- ClinicalTrials.gov ID
- NCT06673004
- Acronym / sponsor ID
- STUDY20241094
- Conditions
- Ovarian Failure, Ovarian Insufficiency, Menopause Ovarian Failure, Menopause, Premature, Infertility, Female, Endocrine Female Infertility
- Keywords
- Primary ovarian insufficiency, Ovarian tissue transplantation, Immunosuppression, Premature menopause, Ovarian failure, Ovary transplant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian tissue recipient | Experimental | Procedure: Ovarian tissue allo-transplantationAny recipient that receives ovarian tissue transplantation |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (38 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian tissue allo-transplantationParticipants will receive donor ovarian tissue with immunosuppression | Procedure or surgery | Ovarian tissue recipient |
Primary outcome
Time (days) from transplantation to resumption of menses as measured by patient report
Time frame: Up to 6 months
Number of live births as measured by medical record report/patient report
Time frame: Up to 3 years
1 secondary outcome
Time (days) from transplantation to pregnancy as measured by medical record/patient report
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
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RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
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RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
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Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Flyckt, MD principal investigator
University Hospitals Cleveland Medical Center
Kathryn Coyne, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian tissue allo-transplantation in people with Ovarian Failure and Ovarian Insufficiency, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Tribout, RN (216-286-0763, Megan.Tribout@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (days) from transplantation to resumption of menses as measured by patient report (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.