Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- HCG stimulation test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Suspected Cushing syndrome patients.
- •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).
- •Patients who took acupuncture treatment within the past 3 months.
- •Patient who are unwilling to give written consent to the study.
研究组 & 干预措施
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.
干预措施: acupuncture protocol 1 (Other)
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.
干预措施: Acupuncture protocol 2 (Other)
结局指标
主要结局
HCG stimulation test
时间窗: 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.
次要结局
- Physical examination(16 weeks)
- menstrual frequency(16 weeks)
- Laboratory examination(16 weeks)
- trans-abdomen ultrasound of the uterus and ovaries(16 weeks)
- Number of Participants with Adverse Events(16 weeks)
- serum levels of the neurotransmitter(16 weeks)
研究者
Dongmei Huang
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital
Huazhong University of Science and Technology