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
2 other identifiers
interventional
210
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2026
CompletedFirst Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
September 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 9, 2026
August 1, 2026
2.5 years
August 19, 2026
September 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HOMA-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.
End of treatment (Week 12)
Secondary Outcomes (17)
HOMA-IR level
Baseline (Week 0) and end of follow-up (Week 24)
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).
Glycated hemoglobin level
Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Serum anti-Müllerian hormone concentration
Baseline (Week 0), Week 12, and Week 24
Serum total cholesterol concentration
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
- +12 more secondary outcomes
Study Arms (2)
Precision Acupuncture Plus Personalized Lifestyle Intervention
EXPERIMENTALParticipants receive model-guided precision acupuncture, with treatment frequency determined by insulin resistance risk and reassessed every 4 weeks, together with a personalized lifestyle intervention based on multimodal data and individualized glucose-response prediction. The treatment period is 12 weeks.
Conventional Acupuncture Plus Lifestyle Intervention
ACTIVE COMPARATORParticipants receive conventional acupuncture together with standard lifestyle management, including exercise and nutritional guidance delivered and monitored through the PCOS health management system. The treatment period is 12 weeks.
Interventions
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 conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2026
First Posted
September 9, 2026
Study Start
July 10, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 9, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared.