International Peace Maternity and Child Health Hospital
Phase
Phase 1/2
Started
2026-03-20
Last updated
2026-04-03
Condition(s) studied
Premature Ovarian Insufficiency
Investigational drug(s) / intervention(s)
YT023Control Arm (Conventional Therapy)
YT023: YT023 is administered via in situ (intra-ovarian) injection
Control Arm (Conventional Therapy): The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site
Study summary
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria:
Able to understand and voluntarily sign the informed consent form (ICF) prior to the initiation of any study-related assessments or procedures; Aged 20 to 39 years (inclusive) at the time of signing the ICF; Meets the diagnostic criteria for premature ovarian insufficiency (POI) ; Has a normal karyotype and no known history of FMR1 premutation (Fragile X syndrome); Has at least one ovary intact.
Exclusion Criteria:
History of primary malignancy; Subjects who are hepatitis B surface antigen (HBsAg)-positive at screening; subjects who are HBsAg-negative but hepatitis B core antibody (HBcAb)-positive with detectable peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection; subjects who are hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; or subjects who are human immunodeficiency virus (HIV) antibody-positive; Known hypersensitivity to any component of the study treatments; Severe neurocognitive impairment as judged by the investigator; Any comorbidities or other conditions that, in the investigator's opinion, may affect compliance with the protocol or render the subject unsuitable for participation in the study
Primary outcome measure(s)
To evaluate the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs). — 2years
Improvement in ovarian reserve function following YT023 treatment. — 2 years Changes in ovarian reserve function following YT023 treatment, including levels of follicle-stimulating hormone (FSH), anti-Müllerian hormone (AMH), estradiol (E2), and antral follicle count (AFC).
Trial sites (1)
Facility
City
Region
Status
International Peace Maternity & Child Health Hospital
Shanghai
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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