ClinicalTrials.gg
RecruitingNCT07809503Updated Sep 9, 2026

Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS

An interventional study of Model-Guided Precision Acupuncture and Personalized Lifestyle Intervention in Polycystic Ovary Syndrome, sponsored by Peking University Third Hospital. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital — 7 open to participants now, 7 under way, none of them phase 3. Polycystic Ovary Syndrome · Peking University Third Hospital.

Planned enrollment
7th of 12
210 · median 255
Started
2026
with 2 others
No phase
11 of 13
6 open now
Registered
12th of 13
by date

Among the 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2026, is one of 11 with no phase, and was the 12th registered.

Polycystic Ovary Syndrome

958 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

Browse Polycystic Ovary Syndrome studies →

Open to participants now

7 of the 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 119 Polycystic Ovary Syndrome studies recruiting now, 11 (9%) set no upper age limit and 105 (88%) stop at 75 or younger; 23 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 40 Years · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Polycystic Ovary Syndrome
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged18-40 years, inclusive.
  • (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 .

Exclusion criteria

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 ( \<60 mL/min), hepatic impairment, disease, or .
  • Type 1 diabetes mellitus or (HbA1c) >53 mmol/mol (7%). - Use, within the past 3 months, of medications that may affect study assessments, including , insulin, glucose-lowering agents such as acarbose, antidepressants, hormonal , 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Precision Acupuncture Plus Personalized Lifestyle Intervention

    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.

    Other: Model-Guided Precision Acupuncture · Behavioral: Personalized Lifestyle Intervention

  • Active comparator
    Conventional Acupuncture Plus Lifestyle Intervention

    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.

    Other: Conventional Acupuncture · Behavioral: Standard Lifestyle Intervention

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.

  • OtherConventional Acupuncture

    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.

06

What researchers measure

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.

    Time frame: End of treatment (Week 12)

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.

Of 203 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 29 months is above that.

Counting every sponsor, half of 218 studies reached it within 18 months; a quarter within 7 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Sep 9, 2026
StartActual
Jul 10, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07809503
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Jul 10, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Haolin Zhang, PhD
Contact
zoe@bjmu.edu.cn
+86 15611963539

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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