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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture protocol 1
Acupuncture protocol 2
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Electro-acupuncture, HCG stimulation test, Menstrual frequency, polycystic ovary syndrome, Randomized, controlled, trial

Eligibility Criteria

18 Years - 28 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Acupuncture protocol 1

Acupuncture protocol 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Laboratory examination
Serum levels of sex hormone steroids including blood follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone, prolactin and total testosterone will be evaluated at baseline and 16 weeks. Oral glucose tolerance test (OGTT) and insulin releasing test will be performed at baseline and 16 weeks. Serum levels of leptin, adiponectin, resistin, adrenal cortical hormone and beta endorphin will be examined at baseline and 16 weeks later.
trans-abdomen ultrasound of the uterus and ovaries
The uterine dimensions, endometrial thickness and echo type, other uterine abnormalities, presence and size of leiomyoma, uterine artery blood flow parameters (pulsation index, resistance index, Shrinkage value / Diastolic value) will be obtained through trans-abdomen ultrasound at baseline and 16 weeks. The ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle (small follicles with mean diameter < 10 mm) count of each ovary; ovarian artery blood flow parameters will be observed through trans-abdomen ultrasound at baseline and 16 weeks later.
Physical examination
Physical examination including vital signs, height, weight, hip and waist measurements, BMI and assessment of hirsutism by Ferriman-Gallwey score and acne standard acne lesion counts will be performed at baseline and 16 weeks.
Number of Participants with Adverse Events
Adverse events happened during 16-week treatment period and 12-week follow-up will be recorded and classified. Unless otherwise formal requirements, each report about the detail and summary of adverse event to data safety supervision and the commission will be reported by double blind way.
menstrual frequency
The menstruation characteristics including menstrual cycle, duration and amount of the past 4 months and during the treatment period will be recorded. Menstrual frequency was calculated by dividing the number of menstrual bleeding by 4.
serum levels of the neurotransmitter
serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.

Full Information

First Posted
December 24, 2012
Last Updated
February 23, 2018
Sponsor
Huazhong University of Science and Technology
Collaborators
Heilongjiang University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01812161
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Heilongjiang University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Electro-acupuncture, HCG stimulation test, Menstrual frequency, polycystic ovary syndrome, Randomized, controlled, trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture protocol 1
Arm Type
Active Comparator
Arm 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.
Arm Title
Acupuncture protocol 2
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
acupuncture protocol 1
Other Intervention Name(s)
real acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture protocol 2
Other Intervention Name(s)
sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCG stimulation test
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Laboratory examination
Description
Serum levels of sex hormone steroids including blood follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone, prolactin and total testosterone will be evaluated at baseline and 16 weeks. Oral glucose tolerance test (OGTT) and insulin releasing test will be performed at baseline and 16 weeks. Serum levels of leptin, adiponectin, resistin, adrenal cortical hormone and beta endorphin will be examined at baseline and 16 weeks later.
Time Frame
16 weeks
Title
trans-abdomen ultrasound of the uterus and ovaries
Description
The uterine dimensions, endometrial thickness and echo type, other uterine abnormalities, presence and size of leiomyoma, uterine artery blood flow parameters (pulsation index, resistance index, Shrinkage value / Diastolic value) will be obtained through trans-abdomen ultrasound at baseline and 16 weeks. The ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle (small follicles with mean diameter < 10 mm) count of each ovary; ovarian artery blood flow parameters will be observed through trans-abdomen ultrasound at baseline and 16 weeks later.
Time Frame
16 weeks
Title
Physical examination
Description
Physical examination including vital signs, height, weight, hip and waist measurements, BMI and assessment of hirsutism by Ferriman-Gallwey score and acne standard acne lesion counts will be performed at baseline and 16 weeks.
Time Frame
16 weeks
Title
Number of Participants with Adverse Events
Description
Adverse events happened during 16-week treatment period and 12-week follow-up will be recorded and classified. Unless otherwise formal requirements, each report about the detail and summary of adverse event to data safety supervision and the commission will be reported by double blind way.
Time Frame
16 weeks
Title
menstrual frequency
Description
The menstruation characteristics including menstrual cycle, duration and amount of the past 4 months and during the treatment period will be recorded. Menstrual frequency was calculated by dividing the number of menstrual bleeding by 4.
Time Frame
16 weeks
Title
serum levels of the neurotransmitter
Description
serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongmei Huang, doctor
Organizational Affiliation
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
027
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
we use the Clinical Trial Management Public Platform to manage and share our date.
IPD Sharing Time Frame
September1th,2019,for 1 year
IPD Sharing Access Criteria
only for research
Citations:
PubMed Identifier
20943753
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.
Results Reference
background
PubMed Identifier
34319506
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.
Results Reference
derived
PubMed Identifier
30843421
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.
Results Reference
derived

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

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