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Polycystic Ovary Syndrome (PCOS)NCT06306417

A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

A study testing lifestyle intervention and acupuncture in people with Polycystic Ovary Syndrome (PCOS), run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
lifestyle intervention and acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
1 siteChina
Study dates
28 Sep 2023to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL

Who cannot join

  • Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
  • Type I diabetes or not well controlled type II diabetes
  • Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
  • Psychiatric diagnoses or using psychiatric medications including antidepressants
  • Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University third hospital

    Beijing

Other trials in China

About this study

Official title: Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

Read the detailed description

A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.

  1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS;
  2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.
Being tested
lifestyle intervention, acupuncture, Sham acupuncture
Keywords
insulin resistance
Medical subject headings
Polycystic Ovary Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lifestyle interventionOther

    lifestyle intervention

  • acupunctureDevice

    acupuncture

  • Sham acupunctureDevice

    Sham acupuncture

Study groups in NCT06306417
Study groupRoleWhat they receive
Experimental groupExperimentalacupuncture
Receives: Other: lifestyle intervention; Device: acupuncture
control groupSham comparatorsham acupuncture
Receives: Other: lifestyle intervention; Device: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HOMA-IR

    calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)

    [Time Frame: Baseline]

    Measured: baseline and after 4 months

Secondary outcomes (29)

  1. Hirsutism(FG score >4）, acne and early alopecia

    general condition

    Measured: baseline and after 4 months

  2. AUC insulin

    during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve

    Measured: baseline and after 4 months

  3. Follicle stimulating hormone (FSH)

    Examined with the blood sample

    Measured: baseline and after 4 months

  4. luteinizing hormone (LH)

    Examined with the blood sample

    Measured: baseline and after 4 months

  5. Progestin (P)

    Examined with the blood sample

    Measured: baseline and after 4 months

  6. Estrogen (E2)

    Examined with the blood sample

    Measured: baseline and after 4 months

  7. Prolactin (PRL)

    Examined with the blood sample

    Measured: baseline and after 4 months

  8. Androgen(T)

    Examined with the blood sample

    Measured: baseline and after 4 months

  9. Anti-mullerian hormone (AMH)

    Examined with the blood sample

    Measured: baseline and after 4 months

  10. Sex hormone-binding globulin (SHBG)

    Examined with the blood sample

    Measured: baseline and after 4 months

  11. Free testosterone index (FAI)

    testosterone (nmol/ml) ×100 / SHBG (nmol/ml).

    Measured: baseline and after treatment

  12. total cholesterol

    Examined with the blood sample

    Measured: baseline and after 4 months

  13. triglycerides

    Examined with the blood sample

    Measured: baseline and after 4 months

  14. high density lipoprotein (HDL)

    Examined with the blood sample

    Measured: baseline and after 4 months

  15. low density lipoprotein (LDL)

    Examined with the blood sample

    Measured: baseline and after 4 months

  16. Bile acidomics

    Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry).

    Measured: baseline and after 4 months

  17. Metagenomics and 16S rDNA sequencing analysis

    gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000.

    Measured: baseline and after 4 months

  18. short form-36 (SF36)

    determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better

    Measured: baseline and after 4 months

  19. Self-Rating Anxiety Scale (SAS)

    determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.

    Measured: baseline and after 4 months

  20. Self-Rating Depress Scale (SDS)

    determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse

    Measured: baseline and after 4 months

  21. polycystic ovary syndrome questionnaire, PCOSQ

    Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS

    Measured: baseline and after 4 months

  22. BMI

    calculation:BMI=weight(kg)/height(m)^2

    Measured: baseline and after 4 months

  23. Fat%

    examined by body composition analyzer

    Measured: baseline and after 4 months

  24. waist to hip ratio(WHR)

    calculation of WHR: waist circumference(cm)/ hip circumference(cm)

    Measured: baseline and after 4 months

  25. glycosylated hemoglobin level

    Examined with the blood sample

    Measured: baseline and after 4 months

  26. ovarian size

    baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm)

    Measured: baseline and after 4 months

  27. number of follicles

    observed by B-ultrasound

    Measured: baseline and after 4 months

  28. uterine size

    observed by B-ultrasound

    Measured: baseline and after 4 months

  29. endometrial thickness

    observed by B-ultrasound

    Measured: baseline and after 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start28 Sep 2023
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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
Single blind
Who is masked
Participant
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306417
Sponsor's protocol ID
PKUTH TCM
Status last verified
Jan 2024
First submitted
19 Feb 2024
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We haven't decided whether to share the data

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle intervention and acupuncture in people with Polycystic Ovary Syndrome (PCOS), run by Peking University Third Hospital at 1 site 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HOMA-IR (time frame: baseline and after 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306417.

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 22 Jun 2025.

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