NCT07806656Not yet recruiting
Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome
Effects of Acupuncture on Homeostatic Model Assessment of Insulin Resistance in Women With Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- Peking University Third Hospital
- NCT number
- NCT07806656
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 20 Aug 2026 to the primary completion date, 1 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Language or mental disorders, or inability to understand the experimental content
Other
- 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
- Mental problems
Who the study is looking for
- 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
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.