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

Huazhong University of Science and Technology

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: acupuncture protocol 1; Other: Acupuncture protocol 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01812161

15002738313766868351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 28 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Acupuncture protocol 1

Active Comparator group

Description:

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.

Treatment:

Other: acupuncture protocol 1

Acupuncture protocol 2

Sham Comparator group

Description:

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.

Treatment:

Other: Acupuncture protocol 2