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.
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 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
Parallel
Active Acupuncture
Procedure/SurgeryActive acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Two standardized sets of acupuncture points are alternated. Sterile needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture (0.3-ms pulse width; approximately 0.1-2.0 mA at a comfortable intensity), while needles not connected to the stimulator are manually stimulated every 10 minutes.
Sham Acupuncture
Procedure/SurgerySham acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (\<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity to mimic active electroacupuncture.
Lifestyle Management
BehavioralAll participants receive individualized lifestyle management beginning at baseline. The program combines face-to-face nutritional consultation with a web- and mobile-based PCOS management platform and wearable step counter. Participants receive individualized dietary and physical activity advice, daily exercise and diet prescriptions, weekly review of weight-loss goals and food diaries, and regular feedback from the research team.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting glucose and fasting insulin concentrations. The primary endpoint is the change in HOMA-IR from baseline to the end of the 12-week treatment period.
Click on the lead sponsor to view all of their trials.
Peking University Third Hospital
Lead sponsor
Beijing Haidian Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
