Clinical trial NCT01812161: Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
Official title: Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Electro-acupuncture
HCG stimulation test
Menstrual frequency
polycystic ovary syndrome
Randomized
controlled
trial
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Heilongjiang University of Chinese Medicine
name: Hubei College of Traditional Chinese Medicine
name: The University of Hong Kong
First posted: 2013-03-18
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: HCG stimulation test
timeFrame: 16 weeks
Secondary outcomes:
measure: Laboratory examination
timeFrame: 16 weeks
measure: trans-abdomen ultrasound of the uterus and ovaries
timeFrame: 16 weeks
measure: Physical examination
timeFrame: 16 weeks
measure: Number of Participants with Adverse Events
timeFrame: 16 weeks
measure: menstrual frequency
timeFrame: 16 weeks
measure: serum levels of the neurotransmitter
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
name: Dongmei Huang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
citation: Dong HX, Wang Q, Wang Z, Wu XK, Cheng L, Zhou ZM, Yang L, Yi P, Huang DM. Impact of Low Frequency Electro-acupuncture on Glucose and Lipid Metabolism in Unmarried PCOS Women: A Randomized Controlled Trial. Chin J Integr Med. 2021 Oct;27(10):737-743. doi: 10.1007/s11655-021-3482-z. Epub 2021 Jul 28.
citation: Wang Z, Dong H, Wang Q, Zhang L, Wu X, Zhou Z, Yang L, Huang D. Effects of electroacupuncture on anxiety and depression in unmarried patients with polycystic ovarian syndrome: secondary analysis of a pilot randomised controlled trial. Acupunct Med. 2019 Feb;37(1):40-46. doi: 10.1136/acupmed-2017-011615. Epub 2019 Mar 7.