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

NCT01812161 | Completed DMC

• 1 other identifier: 15002738313766868351
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Electro-acupuncture; HCG stimulation test; Menstrual frequency; polycystic ovary syndrome; Randomized; controlled; trial

Outcome Measures

Primary Outcomes (1)

• HCG stimulation test

  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.

  16 weeks

Secondary Outcomes (6)

• Laboratory examination

  16 weeks

• trans-abdomen ultrasound of the uterus and ovaries

  16 weeks

• Physical examination

  16 weeks

• Number of Participants with Adverse Events

  16 weeks

• menstrual frequency

  16 weeks

Study Arms (2)

Acupuncture protocol 1

ACTIVE COMPARATOR

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

Acupuncture protocol 2

SHAM COMPARATOR

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

Interventions

acupuncture protocol 1 OTHER

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.

Also known as: real acupuncture

Acupuncture protocol 1

Acupuncture protocol 2 OTHER

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.

Also known as: sham acupuncture

Acupuncture protocol 2

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Unmarried women with age between 18 and 28 years and without bearing requirement within 4 months.
• \) 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.

You may not qualify if:

• \) Patients with hyperprolactinemia.
• \) Patients with androgens secrete increased abnormal which caused by adrenal or ovarian tumors.
• \) 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
• \) 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Heilongjiang University of Chinese Medicine: collaborator
• Hubei College of Traditional Chinese Medicine: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

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

Wuhan, Hubei, 027, China

Location

Related Publications (3)

• 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.

  PMID: 20943753 BACKGROUND

• 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.

  PMID: 34319506 DERIVED

• 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.

  PMID: 30843421 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Dongmei Huang, doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: March 18, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: September1th，2019，for 1 year
• Access Criteria: only for research

Locations

CN (1)