Precision acupuncture and lifestyle for PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, parallel-group randomized trial in adults with PCOS. Participants will be assigned to either model-guided precision acupuncture plus personalized lifestyle interventions or conventional acupuncture plus standard lifestyle changes, with 12 weeks of treatment and risk monitoring guided by traditional Chinese medicine diagnostics. Primary outcome is change in HOMA-IR, with secondary endpoints covering endocrine and metabolic markers, menstrual/ovulatory outcomes, psychological well-being, quality of life, safety, and health-economic impact. The study aims to establish an intelligent, individualized management model for PCOS based on multimodal risk assessment. Results will inform whether the precision approach offers superior metabolic and reproductive benefits over standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged18-40 years, inclusive.
* Body mass index (BMI) of 25-40 kg/m², inclusive.
* Meeting the 2003 Rotterdam diagnostic criteria for polycystic ovary syndrome (PCOS), defined by the presence of at least two of the following three criteria: Oligo-ovulation or anovulation; Clinical and/or biochemical signs of hyperandrogenism; Polycystic ovarian morphology on ultrasonography.
* Willing to participate voluntarily in the study, able to understand the study procedures, and able to provide written informed consent.

Exclusion Criteria:

* Presence of hyperandrogenemia due to other causes, such as hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, or exogenous androgen use.
* Presence of renal disease (creatinine clearance \<60 mL/min), hepatic impairment, autoimmune disease, or malignancy.
* Type 1 diabetes mellitus or glycated hemoglobin (HbA1c) \>53 mmol/mol (7%). - Use, within the past 3 months, of medications that may affect study assessments, including glucocorticoids, insulin, glucose-lowering agents such as acarbose, antidepressants, hormonal contraceptives, ovulation-inducing agents, or other relevant medications.
* Blood pressure \>160/100 mmHg.
* Currently pregnant or breastfeeding, pregnancy within the past 6 months, or planning to become pregnant during the study period.
* Having received continuous acupuncture treatment for at least 2 months prior to study treatment.
* Daily smoking or alcohol consumption.
* Presence of language barriers, psychiatric disorders, or other conditions that may impair the participant's ability to understand the study, comply with the intervention, or complete follow-up assessments.

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Haidian Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Haolin Zhang, PhD
• Email: zoe@bjmu.edu.cn
• Phone: +86 15611963539

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Orlistat for metabolic and hormonal features in women with PCOS

  This trial tests whether adding orlistat to lifestyle advice helps improve metabolic and hormonal aspects in women with PCOS compared to lifestyle advice alone.

  Recruiting Khyber Medical University Peshawar · Abbottābād, Khyber Pakhtunkhwa · NCT07747909

• Physical activity program for women with PCOS and fatty pancreas plus subclinical hypothyroidism

  A program of exercise is being tested to see if it helps women with PCOS who also have fatty pancreas and subclinical hypothyroidism, compared to usual care.

  Recruiting Cairo University · Giza · NCT07591246

• Glucose monitoring in women with polycystic ovary syndrome

  This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.

  Recruiting Centre Hospitalier Universitaire, Amiens · Salouël · NCT07483723

• Adding regular exercise to a low‑calorie diet and metformin for women with PCOS and asthma

  This study will test whether adding regular treadmill walking to a low‑calorie diet and daily metformin helps women who have both PCOS and asthma.

  Recruiting Cairo University · Giza, Dokki · NCT07446985

• Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women

  We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07412028

• Combining Dlbs 3233 with clomiphene citrate for PCOS

  This will test whether adding Dlbs 3233 to clomiphene citrate helps women with PCOS improve insulin resistance (HOMA-IR), follicle maturation, and menstrual cycle regularity.

  Recruiting Early Phase 1 Inlacinpenelitian · Yogyakarta, DIY · NCT07403201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.