Polycystic Ovary Syndrome
Conditions
Brief summary
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.
Interventions
OTHERModel-Guided Precision Acupuncture
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.
BEHAVIORALPersonalized Lifestyle Intervention
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.
BEHAVIORALStandard Lifestyle Intervention
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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR level after 12 weeks of treatment | End of treatment (Week 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR level | Baseline (Week 0) and end of follow-up (Week 24) | 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. |
| Area under the insulin concentration-time curve during the oral glucose tolerance test | Baseline (0 week), end of treatment (12 week) and end of follow-up (24week). | 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. |
| Glycated hemoglobin level | Baseline (0 week), end of treatment (12 week) and end of follow-up (24week). | Glycated hemoglobin (HbA1c) will be measured using the study site's routine clinical laboratory method. |
| Serum anti-Müllerian hormone concentration | Baseline (Week 0), Week 12, and Week 24 | Serum anti-Müllerian hormone (AMH) concentration will be measured using the study site's routine clinical laboratory method. |
| Serum total cholesterol concentration | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Serum total cholesterol (TC) concentration will be measured using the study site's routine clinical laboratory method. |
| Serum triglyceride concentration | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Serum triglyceride (TG) concentration will be measured using the study site's routine clinical laboratory method. |
| Serum high-density lipoprotein cholesterol concentration | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured using the study site's routine clinical laboratory method. |
| Serum low-density lipoprotein cholesterol concentration | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Serum low-density lipoprotein cholesterol (LDL-C) concentration will be measured using the study site's routine clinical laboratory method. |
| Number of menstrual bleeding episodes | During treatment (Weeks 1-12) and during follow-up (Weeks 13-24) | 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. |
| Number of ovulations | During treatment (Weeks 1-12) and during follow-up (Weeks 13-24) | 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. |
| Body weight | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Body weight will be measured in kilograms at each assessment. |
| Body mass index | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). |
| Waist circumference | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Waist circumference will be measured in centimeters using the standardized study measurement procedure. |
| Waist-to-hip ratio | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. A single dimensionless ratio will be reported for each assessment. |
| Modified Ferriman-Gallwey hirsutism score | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | 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. |
| Polycystic Ovary Syndrome Questionnaire total score | Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24) | 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. |
| Number of participants with adverse events | From the first study intervention through the end of follow-up (Week 24) | 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. |
Countries
China
Contacts
CONTACTHaolin Zhang, PhD
Outcome results
None listed