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Could a single infusion restart ovaries in early menopause?

NCT ID NCT05494723

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 39 years

Sex

Female participants only

Healthy volunteers

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

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

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