The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
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ClinicalTrials.gov Identifier: NCT02026323 |
Recruitment Status : Unknown
Verified September 2014 by Yanhua-Zheng, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was: Enrolling by invitation
First Posted : January 1, 2014
Last Update Posted : September 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome Insulin Resistance | Other: acupuncture | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 112 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study |
Study Start Date : | January 2014 |
Estimated Primary Completion Date : | October 2014 |
Estimated Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: acupuncture
"Normal weight" group,the PCOS women with insulin resistance who are normal weight( BMI=18.5-23Kg/m2).The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
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Other: acupuncture
acupuncture |
Experimental: acupuncture 2
"Over weight or obese" group ,the PCOS women with insulin resistance who are overweight or obese: BMI >23 Kg/m2.The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
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Other: acupuncture
acupuncture |
- HOMA-IR [ Time Frame: baseline,treat for 3 and 6 month ,3 or 6 month follow-up ]
- FSH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]Determine FSH by electrogenerated chemiluminescence.
- LH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Androgen [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Progesterone [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Prolactin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Estradiol [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- dehydroepiandrosterone(sodium)sulfate [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- sex hormone binding globulin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- c-peptide [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Apoa1 [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- ApoB [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- TC [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- TG [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- glycosylated hemoglobin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Questionnaire investigation [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]Health related quality of life, affective symptoms and personality: Will be determined by short form-36 (SF36), polycystic ovary syndrome questionnaire (PCOSQ),(generic and diagnosis-specific HRQL questionnaire),and the Chinese Quality of Life (ChQOL) ,and symptoms of anxiety and depression assessed by the Zung Self-Rating Anxiety Scale (Zung SAS) and Zung Self-Rating Depression Scale (Zung SDS).
- Transvaginal ultrasound [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
- Body composition(weight,height,waist circumference,hip circumference) [ Time Frame: baseline,every month in treatment,the follow-up of 3 or 6 month ]

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years.
- BMI ≥18.5Kg/m2
- Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligo-, amenorrhea (less than 8 cycles per year) or/clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
- IR defined by the homeostatic model assessment (HOMA-IR: fasting insulin x fasting glucose/22.5) and 2.14 will be used as the cut off 33.
- No desire of children and using barrier methods of contraception for 1 year.
- Willing to sign the consent form
Exclusion Criteria:
- With other endocrine disorders such as hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone <3nmol/L), and androgen secreting tumors.
- Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry.
- Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- Patients diagnosed with Type I diabetes, or Type I and Type II patients who receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
- Patients with suspected Cushing's syndrome.
- Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
- Pregnancy within the last 6 weeks.
- Post-abortion or postpartum within last 6 weeks.
- Breastfeeding within the last 6 months.
- Patients received Acupuncture treatment related to PCOS within the last 2 months.
- Patients who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss.
- Patients with known congenital adrenal hyperplasia.
- Not willing to give written consent to the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026323
China, Guangdong | |
The first affiliated hospital of Guangzhou Medical University | |
Guangzhou, Guangdong, China, 510120 |
Study Chair: | Hongxia HX Ma, Dorctor | Study sponsor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yanhua-Zheng, Attending physician, The First Affiliated Hospital of Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT02026323 |
Other Study ID Numbers: |
PCOSAir |
First Posted: | January 1, 2014 Key Record Dates |
Last Update Posted: | September 8, 2014 |
Last Verified: | September 2014 |
Polycystic Ovary Syndrome Insulin Resistance Syndrome Disease Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |