Could a single infusion restart ovaries in early menopause?
NCT ID NCT05494723
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called YB-1113 for women with premature ovarian insufficiency (early menopause). The goal is to see if it is safe and can help restart ovarian function, potentially allowing women under 40 to become pregnant. Only 6 participants will receive the treatment by IV infusion.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 39 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Key Inclusion Criteria: 1. Female, 18 to \<40 years old, who are seeking fertility or preservation of fertility 2. Oligo/Amenorrhea for at least 4 months 3. At least two menopausal FSH levels (≥ 25 IU/L) with 4 to 6 weeks interval. 4. AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period). 5. Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening 6. For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies Key Exclusion Criteria: 1. 1\. Primary amenorrhea or FSH ≥ 40 IU/L 2. Presence of contraindications to pregnancy 3. POI due to cytotoxic chemotherapy or radiation therapy 4. Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI 5. Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology. 6. Washout period less than 3 months for HRT. 7. Subjects with a history of breast cancer or other estrogen responsive cancer. 8. Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm. 9. Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease 10. Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS) 11. Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia. 12. Subjects under active management for autoimmune disease. 13. Subjects with intra-uterine devices (IUDs). 14. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study. 15. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin. 16. Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent 17. Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.
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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
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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
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More trials for these conditions
Other studies related to the condition(s) this trial covers.