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Completed

NCT Number: NCT06306417

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

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.

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Key information

About this study

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.

  • To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS;
  • To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

lifestyle intervention

Other

lifestyle intervention

acupuncture

Device

acupuncture

Sham acupuncture

Device

Sham acupuncture

Primary outcomes

  1. HOMA-IR

    Time frame: baseline and after 4 months

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

    [Time Frame: Baseline]

Secondary outcomes

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

    Time frame: baseline and after 4 months

    general condition

  2. AUC insulin

    Time frame: baseline and after 4 months

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

  3. Follicle stimulating hormone (FSH)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  4. luteinizing hormone (LH)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  5. Progestin (P)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  6. Estrogen (E2)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  7. Prolactin (PRL)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  8. Androgen(T)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  9. Anti-mullerian hormone (AMH)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  10. Sex hormone-binding globulin (SHBG)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  11. Free testosterone index (FAI)

    Time frame: baseline and after treatment

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

  12. total cholesterol

    Time frame: baseline and after 4 months

    Examined with the blood sample

  13. triglycerides

    Time frame: baseline and after 4 months

    Examined with the blood sample

  14. high density lipoprotein (HDL)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  15. low density lipoprotein (LDL)

    Time frame: baseline and after 4 months

    Examined with the blood sample

  16. Bile acidomics

    Time frame: baseline and after 4 months

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

  17. Metagenomics and 16S rDNA sequencing analysis

    Time frame: baseline and after 4 months

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

  18. short form-36 (SF36)

    Time frame: baseline and after 4 months

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

  19. Self-Rating Anxiety Scale (SAS)

    Time frame: baseline and after 4 months

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

  20. Self-Rating Depress Scale (SDS)

    Time frame: baseline and after 4 months

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

  21. polycystic ovary syndrome questionnaire, PCOSQ

    Time frame: baseline and after 4 months

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

  22. BMI

    Time frame: baseline and after 4 months

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

  23. Fat%

    Time frame: baseline and after 4 months

    examined by body composition analyzer

  24. waist to hip ratio(WHR)

    Time frame: baseline and after 4 months

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

  25. glycosylated hemoglobin level

    Time frame: baseline and after 4 months

    Examined with the blood sample

  26. ovarian size

    Time frame: baseline and after 4 months

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

  27. number of follicles

    Time frame: baseline and after 4 months

    observed by B-ultrasound

  28. uterine size

    Time frame: baseline and after 4 months

    observed by B-ultrasound

  29. endometrial thickness

    Time frame: baseline and after 4 months

    observed by B-ultrasound

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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