NCT07809503Recruiting
Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS
MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This study is designed as a prospective, multicenter, parallel-group randomized controlled trial to evaluate the effectiveness of a "precision acupuncture + personalized lifestyle" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS). Compared with "conventional acupuncture + standard lifestyle intervention," the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment. The safety of the intervention, improvements in endocrine and metabolic profiles, menstrual and ovulatory outcomes, psychological status, quality of life, and health-economic outcomes will also be evaluated. The study aims to provide evidence for establishing an intelligent and individualized clinical management model for PCOS.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 19 Aug 2026
- Start date
- 10 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University Third Hospital
- NCT number
- NCT07809503
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 10 Jul 2026 to the primary completion date, 31 Dec 2028
- 2 sites 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.
Prior treatment
- Having received continuous acupuncture treatment for at least 2 months prior to study treatment.
Other illness
- Presence of hyperandrogenemia due to other causes, such as hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, or exogenous androgen use.
- 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.
Lab values
- 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.
Other
- Blood pressure \>160/100 mmHg.
- Currently pregnant or breastfeeding, pregnancy within the past 6 months, or planning to become pregnant during the study period.
- Daily smoking or alcohol consumption.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
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 | Recruiting |
| Beijing Haidian Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.