Polycystic Ovary Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Meet both the diagnostic criteria for PCOS and infertility as described above; (2) Aged 20 to 40 years (inclusive); (3) Oligomenorrhea (menstrual cycle > 35 days) or amenorrhea; (4) The subject has been informed of the study details, voluntarily signs the informed consent form, and agrees to participate in this study. Note: Patients who meet all of the above four criteria will be included in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Presence of congenital adrenal hyperplasia, Cushing's syndrome, or other conditions that cause hyperandrogenism or ovulatory dysfunction; (2) Use of hormonal medications (e.g., contraceptives, ovulation-inducing drugs) or medications affecting the nervous or psychiatric system within the past 3 months; (3) Presence of severe heart, liver, or kidney diseases, uncontrolled diabetes, or thyroid disorders; (4) Presence of contraindications to acupuncture or a history of needle phobia; (5) Implanted cardiac pacemaker or claustrophobia (which would affect participation in the fMRI substudy); (6) Presence of severe mental illness or cognitive impairment that precludes cooperation with treatment and evaluation; (7) Current participation in another clinical trial. Note: Patients meeting any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate variability (HRV);Ovulation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual status: Menstrual cycle recovery rate and average cycle length.;Clinical symptoms: Hirsutism score (mFG score) and acne score.;Psychological and quality of life measures: Fertility Problem Inventory (FPI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Fertility Quality of Life Questionnaire (FertiQoL).;Central sympathetic tone: Resting pupil diameter.;Central neuroplasticity: Resting-state functional magnetic resonance imaging (fMRI).;Patient Global Assessment (PGA);Incidence of adverse events (AEs); | — |
Countries
China
Contacts
Tianjin Binhai New Area Hospital of Traditional Chinese Medicine