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Study on the mechanism of acupuncture for polycystic ovary syndrome with insulin resistance based on multimodal brain imaging and machine learning analysis

Study on the mechanism of acupuncture for polycystic ovary syndrome with insulin resistance based on multimodal brain imaging and machine learning analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000292
Enrollment
Unknown
Registered
2024-08-24
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovarian syndrome

Interventions

Acupuncture group:Active Acupuncture
Sham acupuncture group:Sham Acupuncture
Healthy control group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: PCOS-IR Participants: 1. Meet the diagnostic criteria for PCOS. 2. HOMA-IR = 2.14. 3. Age between 18 and 35 years. 4. Not currently pregnant or breastfeeding with no plans for pregnancy in the near future and willing to use barrier contraception for six months. 5. No metal implants in the body and no other contraindications for MRI scanning. 6. Right-handed. 7. Have not received acupuncture or medication treatment within the three months prior to entering the study. 8. Not participating in any other ongoing clinical studies. 9. Have signed the informed consent form and voluntarily agreed to participate in this study. Note: Only participants who meet all nine criteria will be included in this study. Healthy Participants: 1. In good health with all indicators and scale assessments normal. 2. No systemic diseases affecting cognitive function; have not recently taken medications that affect cognitive function; and no diseases that affect neuropsychological testing including severe hearing or vision impairments. 3. Body Mass Index (BMI) between 18.5 kg/m² and 24 kg/m². 4. Age between 18 and 35 years. 5. Not currently pregnant or breastfeeding. 6. No metal implants in the body and no other contraindications for MRI scanning. 7. Right-handed. 8. Have not received acupuncture or medication treatment within the three months prior to entering the study. 9. Not participating in any other ongoing clinical studies. 10. Have signed the informed consent form and voluntarily agreed to participate in this study. Note: Only participants who meet all ten criteria will be included in this study.

Exclusion criteria

Exclusion criteria: PCOS-IR Participants: 1. Those with other endocrine or gynecological disorders such as diabetes Follicle-Stimulating Hormone (FSH) > 15 mIU/ml endometrial abnormalities or adnexal abnormalities. 2. Those with severe primary diseases affecting the cardiovascular liver kidney digestive or hematopoietic systems. 3. Those with progressive malignant tumors or other serious diseases prone to infection and bleeding. 4. Those with impaired consciousness who cannot express subjective discomfort. 5. Those with a tendency to bleed easily a high risk of infection arrhythmias implanted pacemakers severe allergic conditions or skin conditions such as ulcers or scars that prohibit acupuncture. Note: Patients who meet any of the above criteria should be excluded. Healthy Participants: 1. Those with a history of PCOS. 2. Those with significant asymmetry in cranial anatomy or clear lesions found during scanning. 3. Those with a family history of neurological or psychiatric disorders. 4. Those unable to independently cooperate in completing this study. Note: Participants who meet any of the above criteria should be excluded.

Design outcomes

Primary

MeasureTime frame
HOMA-IR;

Secondary

MeasureTime frame
Brain MRI;Psychological health and quality of life assessment indicators (Self-Rating Anxiety Scale score Self-Rating Depression Scale score Revised Polycystic Ovary Syndrome Quality of Life Questionnaire score Pittsburgh Sleep Quality Index score Epworth Sleepiness Scale score Fatigue Severity Scale score Eating Attitudes Test score);Intestinal flora;Intervention assessment indicators (Acupuncture Expectancy Evaluation Clinical Global Impression Scale);Measurements of hyperandrogenism-related symptoms (FG score Rosenfield score);Indicators related to glucose and lipid metabolism (fasting glucose fasting insulin area under glucose curve area under insulin curve HOMA-ß total cholesterol triglycerides HDL cholesterol LDL cholesterol non-HDL cholesterol);Hormonal profile (Luteinizing Hormone/Follicle-Stimulating Hormone ratio total testosterone Free Androgen Index Dehydroepiandrosterone Sulfate);Cognitive-behavioral assessment indicators (Animal Verbal Fluency Test Matching Numbers Planned Coding Planned Connection Non-verbal Matrix Verbal Spatial Relationship Figure Memory Expressive attention Number Detection Receptive Attention Word Series Sentence Repetition Sentence Question);Anthropometric indicators (Body Mass Index weight waist circumference hip circumference waist-to-hip ratio);

Countries

China

Contacts

Public ContactYang Han

West China Hospital of Sichuan University

309110036@qq.com+86 13880006127

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026