Polycystic Ovary SyndromeNCT07809503
Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS
A study testing Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention and Conventional Acupuncture in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention and Conventional Acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality, 100080
Haolin Zhang, PhD, +86-10-82264627, zoe@bjmu.edu.cn
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Haolin Zhang, PhD, +86-10-82264627, zoe@bjmu.edu.cn
About this study
Official title: MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention, Conventional Acupuncture, Standard Lifestyle Intervention
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-Guided Precision AcupunctureOther
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.
Personalized Lifestyle InterventionBehavioural
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.
Conventional AcupunctureOther
Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
Standard Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision Acupuncture Plus Personalized Lifestyle Intervention | Experimental | Participants 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. Receives: Other: Model-Guided Precision Acupuncture; Behavioral: Personalized Lifestyle Intervention |
| Conventional Acupuncture Plus Lifestyle Intervention | Active comparator | Participants 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. Receives: Other: Conventional Acupuncture; Behavioral: Standard Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment (Week 12)
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Body weight
Body weight will be measured in kilograms at each assessment.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first study intervention through the end of follow-up (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809503
- Sponsor's protocol ID
- PKUTH TCM
- Other IDs
- 2026-2-40912
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis
- ClinicalTrials.gov ID
- NCT07809503
- Acronym / sponsor ID
- PKUTH TCM
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Acupuncture Plus Personalized Lifestyle Intervention | Experimental | Other: Model-Guided Precision Acupuncture, Behavioral: Personalized Lifestyle InterventionParticipants 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 comparator | Other: Conventional Acupuncture, Behavioral: Standard Lifestyle InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Model-Guided Precision AcupunctureAcupuncture 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. | Other | Precision Acupuncture Plus Personalized Lifestyle Intervention |
| Personalized Lifestyle InterventionParticipants 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. | Behavioural | Precision Acupuncture Plus Personalized Lifestyle Intervention |
| Conventional AcupunctureParticipants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians. | Other | Conventional Acupuncture Plus Lifestyle Intervention |
| Standard Lifestyle InterventionParticipants 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. | Behavioural | Conventional Acupuncture Plus Lifestyle Intervention |
Primary outcome
HOMA-IR level after 12 weeks of treatment
Time frame: 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.
17 secondary outcomes
HOMA-IR level
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
Time frame: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Glycated hemoglobin level
Time frame: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Serum anti-Müllerian hormone concentration
Time frame: Baseline (Week 0), Week 12, and Week 24
Serum total cholesterol concentration
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum triglyceride concentration
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum high-density lipoprotein cholesterol concentration
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum low-density lipoprotein cholesterol concentration
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of menstrual bleeding episodes
Time frame: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Number of ovulations
Time frame: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Body weight
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Body mass index
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist circumference
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist-to-hip ratio
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Modified Ferriman-Gallwey hirsutism score
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Polycystic Ovary Syndrome Questionnaire total score
Time frame: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of participants with adverse events
Time frame: From the first study intervention through the end of follow-up (Week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention and Conventional Acupuncture in people with Polycystic Ovary Syndrome, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haolin Zhang, PhD (+86 15611963539, zoe@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA-IR level after 12 weeks of treatment (time frame: End of treatment (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.