- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01812161
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including menstrual frequency,human chorionic gonadotropin (HCG) stimulation test,physical examination,trans-abdomen ultrasound of the uterus and ovaries, serum levels of sex hormone steroids) will be taken.
Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and menstrual frequency will be recorded during the 12 weeks of follow-up after the treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hubei
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Wuhan, Hubei, China, 027
- Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) Unmarried women with age between 18 and 28 years and without bearing requirement within 4 months.
- 2) Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligomenorrhea(Menstrual cycle> 35 days, and less than 8 cycles per year), or amenorrhea (Menstrual cycle> 90 days) and one of the following two criteria; clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
Exclusion Criteria:
- 1) Patients with hyperprolactinemia.
- 2) Patients with androgens secrete increased abnormal which caused by adrenal or ovarian tumors.
- 3) Patients with uncorrected thyroid disease[thyroid-stimulating hormone (TSH) <0.2 milli-International Unit /milliliter(mIU/mL) or >5.5 mIU/mL]except the patients with normal TSH in the past 1 year.
- 4)Suspected Cushing syndrome patients.
- 5)Patients who Received Estrogen, Progesterone or Oral contraceptives Oral contraceptives and hormone medications within the past 1 months. It takes at least one month to Eliminate these medicines, or it will influence the results
- 6) Patients who Received other medications that have influence on Reproductive function. or metabolism within the past 2 months( such as Anti obesity medications,Anti diabetic medications, traditional Chinese medicine and so on).
- 7)Patients who took acupuncture treatment within the past 3 months.
- 8)Patient who are unwilling to give written consent to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Acupuncture protocol 1
Acupuncture protocol 1:participants will receive treatment (acupuncture protocol 1, real acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks.
Each treatment session lasts for 30 minutes.
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Disposable, single-use, sterilized needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50mm (Wuxi Jiajian Medical Instrument.
251226 Wuxi, China) will be inserted to a depth of 15-35 mm in some acupoints.
After getting the needle sensation (de qi), some acupoints will receive electrical stimulation and the others will receive manual stimulation.
All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks.
Each treatment session lasts for 30 minutes.
Other Names:
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Sham Comparator: Acupuncture protocol 2
Acupuncture protocol 2:participants will receive treatment (acupuncture protocol 2, sham acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks.
Each treatment session lasts for 30 minutes.
All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks.
Each treatment session lasts for 30 minutes.
|
Disposable, single-use, sterilized needles (0.20 x 20mm) made of stainless steel will be inserted to a depth of <5 mm at non-acupoints without evoking the needle sensation (Deqi).
Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture protocol 1 group.
No manual stimulation of the needles will be performed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCG stimulation test
Time Frame: 16 weeks
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Human chorionic gonadotrophin (HCG) stimulation test: Both at baseline and in one week after the treatment, the patients will receive an intramuscular injection of 5000 IU HCG, and 24 h and 48 h later, serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T) of the patients will be detected.
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratory examination
Time Frame: 16 weeks
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Serum levels of sex hormone steroids including blood follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone, prolactin and total testosterone will be evaluated at baseline and 16 weeks.
Oral glucose tolerance test (OGTT) and insulin releasing test will be performed at baseline and 16 weeks.
Serum levels of leptin, adiponectin, resistin, adrenal cortical hormone and beta endorphin will be examined at baseline and 16 weeks later.
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16 weeks
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trans-abdomen ultrasound of the uterus and ovaries
Time Frame: 16 weeks
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The uterine dimensions, endometrial thickness and echo type, other uterine abnormalities, presence and size of leiomyoma, uterine artery blood flow parameters (pulsation index, resistance index, Shrinkage value / Diastolic value) will be obtained through trans-abdomen ultrasound at baseline and 16 weeks.
The ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle (small follicles with mean diameter < 10 mm) count of each ovary; ovarian artery blood flow parameters will be observed through trans-abdomen ultrasound at baseline and 16 weeks later.
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16 weeks
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Physical examination
Time Frame: 16 weeks
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Physical examination including vital signs, height, weight, hip and waist measurements, BMI and assessment of hirsutism by Ferriman-Gallwey score and acne standard acne lesion counts will be performed at baseline and 16 weeks.
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16 weeks
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Number of Participants with Adverse Events
Time Frame: 16 weeks
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Adverse events happened during 16-week treatment period and 12-week follow-up will be recorded and classified.
Unless otherwise formal requirements, each report about the detail and summary of adverse event to data safety supervision and the commission will be reported by double blind way.
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16 weeks
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menstrual frequency
Time Frame: 16 weeks
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The menstruation characteristics including menstrual cycle, duration and amount of the past 4 months and during the treatment period will be recorded.
Menstrual frequency was calculated by dividing the number of menstrual bleeding by 4.
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16 weeks
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serum levels of the neurotransmitter
Time Frame: 16 weeks
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serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.
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16 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dongmei Huang, doctor, Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
Publications and helpful links
General Publications
- Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
- Dong HX, Wang Q, Wang Z, Wu XK, Cheng L, Zhou ZM, Yang L, Yi P, Huang DM. Impact of Low Frequency Electro-acupuncture on Glucose and Lipid Metabolism in Unmarried PCOS Women: A Randomized Controlled Trial. Chin J Integr Med. 2021 Oct;27(10):737-743. doi: 10.1007/s11655-021-3482-z. Epub 2021 Jul 28.
- Wang Z, Dong H, Wang Q, Zhang L, Wu X, Zhou Z, Yang L, Huang D. Effects of electroacupuncture on anxiety and depression in unmarried patients with polycystic ovarian syndrome: secondary analysis of a pilot randomised controlled trial. Acupunct Med. 2019 Feb;37(1):40-46. doi: 10.1136/acupmed-2017-011615. Epub 2019 Mar 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15002738313766868351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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