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PCOSPCOSNCT04193371

Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )

A study testing Active acupuncture and Lifestyle management in people with PCOS and Overweight, 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

This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic… Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
PCOS, Overweight, Obesity
What is being tested?
Active acupuncture and Lifestyle management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteChina
Study dates
6 Dec 2019to 31 Dec 2024
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 20 to 40 years
  • BMI≥ 24 to <40
  • 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.
  • Controls should have BMI>25to<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound

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
  • 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.
  • Pregnancy or breastfeeding the last 6 months
  • Acupuncture last 3 months
  • Daily smoking and alcoholic intake

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China

This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.

Read the detailed description

Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is ~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.

Conditions
PCOS, Overweight, Obesity
Being tested
Active acupuncture, Sham acupuncture, Lifestyle management
Keywords
PCOS, Overweight, Obesity, Acupuncture, Lifestyle management
Medical subject headings
Overweight, Obesity

What participants receive

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

  • Active acupunctureOther

    The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.

  • Sham acupunctureOther

    In the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.

  • Lifestyle managementOther

    All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).

    All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.

Study groups in NCT04193371
Study groupRoleWhat they receive
active acupuncture + lifestyle managementExperimentalParticipants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.
Receives: Other: Active acupuncture; Other: Lifestyle management
control acupuncture + lifestyle managementSham comparatorParticipants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.
Receives: Other: Sham acupuncture; Other: Lifestyle management

What is being measured

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

  1. Body mass index (BMI)

    PCOS's weight in kilograms divided by the square of her height in meters, reported in kg/m2

    Measured: After 4 months of intervention;

Secondary outcomes (42)
  1. total body fat

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  2. body fat and lean ratio

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  3. visceral fat

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  4. basal metabolic rate

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  5. antral follicle count

    examined the ovarian morphology with the B-ultrasound

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  6. sex hormone binding globulin (SHBG)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  7. anti-mullerian hormone (AMH)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  8. follicle stimulating hormone (FSH)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  9. luteinizing hormone (LH)

    examined with the blood sample

    Measured: After 4 months of intervention Follow-up 4 months after last treatment.,

  10. Progestin (P)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  11. Estrogen (E2)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  12. Androgen(T)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  13. Androstenedione (A2)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  14. HOMA-IR

    will be assessed during the oral glucose tolerance test (OGTT) , calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  15. HOMA- β

    will be assessed during the oral glucose tolerance test (OGTT) ,calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  16. glycated hemoglobin ( HbA1c)

    The insulin and glucose response in blood

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  17. total cholesterol

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  18. triglycerides

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  19. high density lipoprotein (HDL)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  20. low density lipoprotein (LDL)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  21. lipometabonomic/lipidomics

    Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group.

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  22. bile acid omics

    Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  23. β-endorphin

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  24. 5- hydroxytryptamine (5-HT)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  25. FerrimanGallwey (FG )value

    To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse.

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  26. short form-36 (SF36)

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

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  27. EuroQol health index scale (EQ-5D)

    determine the health quality of life by the questionnaire of EQ-5D (0-100 score), the higher, the better.

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  28. polycystic ovary syndrome questionnaire (PCOSQ);

    determine the Effects of PCOS specific symptoms on the participants by the questionnaire of and polycystic ovary syndrome questionnaire (PCOSQ)(26-182 score); the higher, the better.

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  29. Self-Rating Anxiety Scale (SAS)

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

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  30. Self-Rating Depress Scale (SDS)

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

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  31. Body mass index (BMI)

    Weight in kilograms divided by the square of her height in meters, reported in kg/m2

    Measured: Follow-up 4 months after last treatment.

  32. Fibroblast growth factor 19(FGF-19)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  33. Ghrelin

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  34. Interleukin 6( IL-6 )

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  35. Interleukin 8( IL-8 )

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  36. Interleukin 22( IL-22 )

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  37. Tumor Necrosis Factor-Alpha (TNF-α)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  38. Gamma-Amino Butyric Acid(GABA)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  39. dopamine(DA)

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  40. Glutamate

    examined with the blood sample

    Measured: After 4 months of intervention, Follow-up 4 months after last treatment.

  41. proteomics

    Detection with the Proteomic techniques in blood, the sample size is about 30 participants in each group.

    Measured: After 4 months of intervention

  42. branched-chain amino acids

    examined with the blood sample, the sample size is about 30 participants in each group.

    Measured: After 4 months of intervention

Timeline

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

  1. First posted10 Dec 2019
  2. Study start6 Dec 2019
  3. Primary completion1 Dec 2024
  4. Study completion31 Dec 2024

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
Model description
This is a cross-sectional case-control part and an open-labelled RCT with a comparative effectiveness design. The inter-ventions to be tested are (1) acupuncture during 4 months+lifestylemanagement; (3) sham acupuncture+lifestyle management
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193371
Sponsor's protocol ID
PekingUTH TCM
Acronym
PCOS
Status last verified
Mar 2025
First submitted
6 Nov 2019
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Active acupuncture and Lifestyle management in people with PCOS and Overweight, 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 4 inclusion and 6 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?

Body mass index (BMI) (time frame: After 4 months of intervention;). 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 22 Jun 2025.

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