Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01812161|
Recruitment Status : Unknown
Verified February 2016 by Dongmei Huang, Huazhong University of Science and Technology.
Recruitment status was: Recruiting
First Posted : March 18, 2013
Last Update Posted : February 23, 2016
|Condition or disease||Intervention/treatment|
|Polycystic Ovary Syndrome||Other: acupuncture protocol 1 Other: Acupuncture protocol 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
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.
Other: acupuncture protocol 1
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 Name: real acupuncture
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.
Other: Acupuncture protocol 2
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 Name: sham acupuncture
- HCG stimulation test [ Time Frame: 16 weeks ]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.
- Laboratory examination [ Time Frame: 16 weeks ]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
- trans-abdomen ultrasound of the uterus and ovaries [ Time Frame: 16 weeks ]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.
- Physical examination [ Time Frame: 16 weeks ]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.
- Number of Participants with Adverse Events [ Time Frame: 16 weeks ]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.
- menstrual frequency [ Time Frame: 16 weeks ]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.
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): NCT01812161
|Contact: Dongmei Huang, doctor||15327130928 ext email@example.com|
|Contact: Xiaoke Wu, doctor||13796025599 ext firstname.lastname@example.org|
|Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 027|
|Contact: Donemei Huang, doctor 15327130928 email@example.com|
|Contact: Qing Wang, doctor 15002738336 firstname.lastname@example.org|
|Sub-Investigator: Qing Wang, doctor|
|Sub-Investigator: Shuang Wu|
|Principal Investigator: Zhongming Zhou, doctor|
|Sub-Investigator: Haoxu Dong, master|
|Principal Investigator: Dongmei Huang, doctor|
|Principal Investigator: Xiaoke Wu, doctor|
|Principal Investigator:||Dongmei Huang, doctor||Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology|