Ovarian Tissue Allo-transplantation

NCT06673004 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20241094
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Primary ovarian insufficiency; Ovarian tissue transplantation; Immunosuppression; Premature menopause; Ovarian failure; Ovary transplant

Outcome Measures

Primary Outcomes (2)

• Time (days) from transplantation to resumption of menses as measured by patient report

  Up to 6 months

• Number of live births as measured by medical record report/patient report

  Up to 3 years

Secondary Outcomes (1)

• Time (days) from transplantation to pregnancy as measured by medical record/patient report

  Up to 2 years

Study Arms (1)

Ovarian tissue recipient

EXPERIMENTAL

Any recipient that receives ovarian tissue transplantation

Procedure: Ovarian tissue allo-transplantation

Interventions

Ovarian tissue allo-transplantation PROCEDURE

Participants will receive donor ovarian tissue with immunosuppression

Ovarian tissue recipient

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Rebecca Flyckt: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Menopause, Premature; Infertility, Female; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Rebecca Flyckt, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Kathryn Coyne, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Tribout, RN

CONTACT

216-286-0763; Megan.Tribout@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief, Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)