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Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Heilongjiang University of Chinese Medicine
Hubei University of Traditional Chinese Medicine
The University of Hong Kong
Information provided by (Responsible Party):
Dongmei Huang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01812161
First received: December 24, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the Human chorionic gonadotrophin (HCG) stimulation test ,also,we hypothesize that EA is more efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.


Condition Intervention
Polycystic Ovary Syndrome
Other: acupuncture protocol 1
Other: Acupuncture protocol 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • HCG stimulation test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Laboratory examination [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 54
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812161

Contacts
Contact: Dongmei Huang, doctor 15327130928 ext 02783663275 hdmjcr@qq.com
Contact: Xiaoke Wu, doctor 13796025599 ext 045182118464 xiaokewu2002@vip.sina.com

Locations
China, Hubei
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    hdmjcr@qq.com   
Contact: Qing Wang, doctor    15002738336    qingpin6686@126.com   
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         
Sponsors and Collaborators
Huazhong University of Science and Technology
Heilongjiang University of Chinese Medicine
Hubei University of Traditional Chinese Medicine
The University of Hong Kong
Investigators
Principal Investigator: Dongmei Huang, doctor Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
  More Information

Publications:
Responsible Party: Dongmei Huang, Department of Integrated Traditional Chinese and Western Medicine Tongji hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01812161     History of Changes
Other Study ID Numbers: 15002738313766868351
Study First Received: December 24, 2012
Last Updated: November 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by Huazhong University of Science and Technology:
Electro-acupuncture
HCG stimulation test
Menstrual frequency
polycystic ovary syndrome
Randomized
controlled
trial

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014