NCT07806656
Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome
Not Yet Recruiting · Not Applicable · Peking University Third Hospital · registry updated 2026-09-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.
Inclusion
- Age 20 to 40 years
- BMI ≥ 24 and \<40
- PCOS diagnosis according to Rotterdam criteria 2003 \[23\] with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
- Voluntarily participate in this research project and sign the informed consent form
Exclusion
- Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia
- Type I diabetes or not well controlled type II diabetes
- Pharmacological or acupuncture treatment within past 3 months
- Pregnancy or breastfeeding in the last 6 months
- Blood pressure \>160/100mmHg
- Daily smoking and alcoholic intake