An interventional study of Active Acupuncture and Sham Acupuncture in Polycystic Ovary Syndrome, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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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.
Among the 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital, this one is the 8th 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 13th registered.
958 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
Browse Polycystic Ovary Syndrome studies →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:
Peking University Third Hospital · Sites in China
Ages 18–40 · Women only
Peking University Third Hospital · Sites in China
Ages 20–40 · Women only
Peking University Third Hospital · Sites in China
Ages 20–40 · Women only
Peking University Third Hospital · Sites in China
Ages 18–40 · Women only
Peking University Third Hospital · Sites in China
Ages 18–40 · Women only
By country, each count listing its studies:
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: 20 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 204 is above the median of 70 across 699 interventional studies indexed under Polycystic Ovary Syndrome.
Median enrollment 255 across the 12 interventional studies, 733 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Peking University Third Hospital is the lead sponsor of 755 studies on the registry; 276 are open to participants now.
1 of the studies in Polycystic Ovary Syndrome by Peking University Third Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06775093Peking University Third HospitalEffects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity | 2026-12-31 |
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Among the 13 studies in Polycystic Ovary Syndrome by Peking University Third Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder among women of reproductive age. Insulin resistance is considered an important pathogenic feature of PCOS and is associated with hyperandrogenism, ovulatory dysfunction, infertility, and an increased long-term risk of type 2 diabetes and cardiovascular disease. Although acupuncture has been used for reproductive and metabolic disorders, evidence regarding its effects on insulin resistance in women with PCOS remains limited.
This clinical research programme consists of two sequential phases. Phase I is a prospective, single-centre, open-label, single-arm exploratory clinical trial. A total of 20 women with PCOS will be enrolled, and all participants will receive active acupuncture plus lifestyle management. The objectives of Phase I are to evaluate the safety, tolerability, and feasibility of the intervention and to explore its preliminary effects on insulin resistance in women with PCOS.
Participants will receive 30-minute acupuncture sessions three times per week for 12 consecutive weeks, for a maximum of 36 treatment sessions. Active acupuncture will be performed using two standardized sets of acupuncture points that will be used alternately. Needles will be inserted to an appropriate depth and manually stimulated to elicit de qi. Selected acupuncture points will receive low-frequency electrical stimulation at 2 Hz. Acupuncture points not connected to the electrical stimulator will be manually stimulated at regular intervals during each treatment session.
All participants will receive individualized lifestyle management beginning at baseline. The lifestyle programme combines nutritional consultation, dietary and physical activity guidance, a web- and mobile-based PCOS management platform, and a wearable step counter. Participants will record their dietary intake and physical activity and will receive regular feedback from the research team.
The Phase I treatment period will last 12 weeks, followed by a 12-week post-treatment follow-up period. Outcomes will be assessed at baseline, Week 12, and Week 24. Safety outcomes will include adverse events, treatment-related adverse events, serious adverse events, and treatment discontinuations. Preliminary effectiveness will be assessed primarily by the change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. Outcomes at Week 24 will be used to explore the durability of the intervention effects.
Secondary and exploratory outcomes will include anthropometric measurements and body composition; glucose metabolism and insulin resistance parameters; reproductive endocrine parameters; lipid profiles; menstrual frequency; ovarian morphology and ovulation status; health-related quality of life; anxiety and depression symptoms; traditional Chinese medicine constitution characteristics; treatment adherence; and participant retention. Adverse events will be monitored throughout the treatment and follow-up periods.
The magnitude and variability of the change in HOMA-IR, together with the safety, feasibility, recruitment, adherence, and dropout findings obtained from Phase I, will be used to determine whether the clinical research programme should proceed to Phase II. These Phase I data will also be used to calculate the required sample size and finalize the detailed design of the Phase II trial. Therefore, the Phase II sample size has not yet been fixed and may change according to the Phase I results.
If the Phase I findings support progression, Phase II will be conducted as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled clinical trial. Eligible participants will be randomly allocated in a 1:1 ratio to one of the following groups:
Active acupuncture plus lifestyle management.
Sham acupuncture plus lifestyle management.
Participants in both Phase II groups will receive 30-minute active or sham acupuncture sessions three times per week for 12 consecutive weeks, followed by a 12-week follow-up period. Active acupuncture will follow the standardized protocol used and evaluated in Phase I. Sham acupuncture will involve superficial needle insertion at non-acupuncture and non-meridian points without manual stimulation. Electrodes will be attached, but the electrical stimulator will be set to zero intensity.
All Phase II participants will receive the same standardized lifestyle-management programme. Outcomes are planned to be assessed at baseline, Week 12, and Week 24. The principal Phase II efficacy outcome is expected to be the between-group difference in the change in HOMA-IR from baseline to Week 12. Phase II will confirm the effectiveness and safety of active acupuncture plus lifestyle management compared with sham acupuncture plus lifestyle management. The final Phase II protocol, outcome hierarchy, statistical analysis plan, and sample size will be specified after the Phase I results have been reviewed and before Phase II recruitment begins.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive sham acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (\<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter.
Procedure: Sham Acupuncture · Behavioral: Lifestyle Management
Participants receive active acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions), using alternating standardized sets of acupuncture points. Needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture at a comfortable intensity of 0.1-2.0 mA; other needles are manually stimulated every 10 minutes. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter.
Procedure: Active Acupuncture · Behavioral: Lifestyle Management
Active acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Two standardized sets of acupuncture points are alternated. Sterile needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture (0.3-ms pulse width; approximately 0.1-2.0 mA at a comfortable intensity), while needles not connected to the stimulator are manually stimulated every 10 minutes.
Sham acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (\<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity to mimic active electroacupuncture.
All participants receive individualized lifestyle management beginning at baseline. The program combines face-to-face nutritional consultation with a web- and mobile-based PCOS management platform and wearable step counter. Participants receive individualized dietary and physical activity advice, daily exercise and diet prescriptions, weekly review of weight-loss goals and food diaries, and regular feedback from the research team.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting glucose and fasting insulin concentrations. The primary endpoint is the change in HOMA-IR from baseline to the end of the 12-week treatment period.
Time frame: Baseline and Week 12 (end of treatment)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2029, 39 months later.
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 39 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.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital →