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Effect of Low-frequency Electroacupuncture (EA) on Ovulation Rate of Unmarried Women With Polycystic Ovary Syndrome


N/A
18 Years
28 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

Effect of Low-frequency Electroacupuncture (EA) on Ovulation Rate of Unmarried Women With Polycystic Ovary Syndrome


First, patients will be recruited according to the inclusion criteria and exclusion
criteria.

Second, baseline measurements (including physical Examination, menstrual History,
trans-abdomen ultrasound of the uterus and ovaries, human chorionic gonadotropin (HCG)
stimulation test, serum levels of sex hormone steroids, lipid, glucose, insulin, adrenal
cortical hormone and beta endorphin) will be taken.

Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.

Fourth, the ovulation rate will be evaluated during the 16-week treatment and 12-week
follow-up.

Last, the above baseline measurements will be taken again as soon as the treatment is
finished, and 12 weeks after the treatment.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

ovulation rate

Outcome Description:

Ask the patient to record the basic temperature every morning, and draw blood to test serum progestin on the first day after the temperature is elevated. Ovulation is defined when the serum progesterone>3ng/mL. Record the ovulation and evaluate the ovulation rate during the 16 weeks of treatment and the following 12 weeks.

Outcome Time Frame:

28 weeks

Safety Issue:

No

Principal Investigator

Dongmei Huang, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology

Authority:

China: Ethics Committee

Study ID:

15002738313766868351

NCT ID:

NCT01812161

Start Date:

March 2013

Completion Date:

April 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • electroacupuncture
  • ovulation rate
  • unmarried women
  • polycystic ovary syndrome
  • Randomized
  • controlled
  • trial
  • Polycystic Ovary Syndrome

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