Premature Ovarian Insufficiency
Conditions
Keywords
POI
Brief summary
Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Premature Ovarian Insufficiency
Detailed description
Premature ovarian insufficiency (POI) is a devastating disease for young women who have not yet completed childbearing.The current clinical diagnostic criteria for POI include oligomenorrhea or amenorrhea lasting more than 4 months before the age of 40, along with two measurements of serum follicle-stimulating hormone (FSH) levels \>25 IU/L, taken at least 4 weeks apart. Given the progressive nature of POI, recent domestic expert consensus has proposed the concept of "subclinical POI", defined by FSH levels of 15-25 IU/L, which may facilitate early identification and intervention in clinical practice. As the etiology of POI remains incompletely understood, early-stage patients often present with non-specific clinical manifestations, rapid disease progression, and once ovarian function is exhausted, there are currently no effective therapies to fundamentally restore it. Therefore, early intervention in high-risk women with fertility needs is of particular clinical importance. This interventional, open-label clinical study is designed to evaluate the safety and efficacy of intra-ovarian administration of YT023 in women with premature ovarian insufficiency (POI). The study aims to assess whether YT023 can improve ovarian function.
Interventions
BIOLOGICALYT023
YT023 is administered via in situ (intra-ovarian) injection
The control group will receive assisted reproductive therapy in accordance with the standard of care at the study site
Sponsors
International Peace Maternity and Child Health Hospital
Shanghai Yuantian Biotechnology Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the clinical benefit of changes in patient-reported quality of life. | 2years | Fertility Quality of Life (FertiQoL) questionnaire |
Countries
China
Outcome results
None listed