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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Acupuncture treatment is guided by a multimodal risk-stratification model using clinical and noninvasive indicators. Participants receive one of two standardized alternating acupuncture prescriptions with manual and 2-Hz electroacupuncture for 30 minutes. Treatment frequency is adjusted according to insulin resistance risk: three sessions per week for high risk, two sessions per week for moderate risk, and one session per week for low risk. Risk is reassessed every 4 weeks during the 12-week treatment period.
Participants receive personalized dietary and lifestyle guidance generated from multimodal data, including dietary images, continuous glucose monitoring data, traditional Chinese medicine constitution, body mass index, body fat percentage, blood pressure, and heart rate. Foods are dynamically classified as green, orange, or red according to predicted individual glucose responses, and recommendations are adjusted throughout the 12-week intervention.
Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
Participants receive standard exercise and nutritional guidance through the PCOS health management system. Exercise is guided and monitored using step-count data, while dietary prescriptions and remote health guidance are delivered through a mobile application and computer-based platform.
Beijing Haidian Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGHOMA-IR level after 12 weeks of treatment
Fasting venous blood samples will be collected to measure fasting plasma glucose and fasting insulin. HOMA-IR will be calculated using the following formula: HOMA-IR = fasting plasma glucose (mmol/L) × fasting insulin (μIU/mL) / 22.5.
Time frame: End of treatment (Week 12)
HOMA-IR level
Fasting venous blood samples will be collected to measure fasting plasma glucose and fasting insulin. HOMA-IR will be calculated using the following formula: HOMA-IR = fasting plasma glucose (mmol/L) × fasting insulin (μIU/mL) / 22.5.
Time frame: Baseline (Week 0) and end of follow-up (Week 24)
Area under the insulin concentration-time curve during the oral glucose tolerance test
The area under the insulin concentration-time curve (insulin AUC) will be calculated from insulin concentrations measured during the oral glucose tolerance test (OGTT). A single insulin AUC value will be reported for each assessment.
Time frame: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Glycated hemoglobin level
Glycated hemoglobin (HbA1c) will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Serum anti-Müllerian hormone concentration
Serum anti-Müllerian hormone (AMH) concentration will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (Week 0), Week 12, and Week 24
Serum total cholesterol concentration
Serum total cholesterol (TC) concentration will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum triglyceride concentration
Serum triglyceride (TG) concentration will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum high-density lipoprotein cholesterol concentration
Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum low-density lipoprotein cholesterol concentration
Serum low-density lipoprotein cholesterol (LDL-C) concentration will be measured using the study site's routine clinical laboratory method.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of menstrual bleeding episodes
articipants will record menstrual bleeding using menstrual cycle diaries. The number of menstrual bleeding episodes will be summarized separately during the 12-week treatment period and the 12-week follow-up period.
Time frame: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Number of ovulations
Ovulatory status will be assessed using menstrual cycle records. When clinically necessary, gynecologic ultrasonography will be used to assess follicular development and endometrial changes. The number of ovulations will be summarized separately during the treatment and follow-up periods.
Time frame: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Body weight
Body weight will be measured in kilograms at each assessment.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Body mass index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist circumference
Waist circumference will be measured in centimeters using the standardized study measurement procedure.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist-to-hip ratio
Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. A single dimensionless ratio will be reported for each assessment.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Modified Ferriman-Gallwey hirsutism score
Hirsutism will be assessed using the modified Ferriman-Gallwey score. Terminal hair growth in nine androgen-sensitive body areas is scored from 0 to 4, producing a total score ranging from 0 to 36. Higher scores indicate more severe hirsutism.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Polycystic Ovary Syndrome Questionnaire total score
Health-related quality of life will be assessed using the 30-item Polycystic Ovary Syndrome Questionnaire (PCOSQ) described in the protocol. Each item is scored from 1 to 7. The total score is calculated as the sum of all item scores and ranges from 30 to 210, with higher scores indicating better health-related quality of life.
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of participants with adverse events
Adverse events will be recorded at each study visit and classified as mild, moderate, or severe. Events of interest include hypoglycemia, defined as blood glucose below 3.9 mmol/L; acute diabetic complications; and acupuncture-related events such as bleeding, hematoma, fainting, needling-site pain, and elevated blood pressure. The number and percentage of participants experiencing at least one adverse event will be reported.
Time frame: From the first study intervention through the end of follow-up (Week 24)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.