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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol

NCT02653911

Polycystic Ovary Syndrome

UNKNOWN NA

Acupuncture for Polycystic Ovarian Syndrome

NCT00602940

Polycystic Ovary Syndrome

UNKNOWN NA

Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

NCT04509817

Polycystic Ovary Syndrome Oligomenorrhea

UNKNOWN NA

Auricular Acupressure (AA) For Overweight/Obese Adolescent and Young Polycystic Ovary Syndrome ( PCOS)

NCT02326714

Polycystic Ovary Syndrome

UNKNOWN NA

The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

NCT02729545

Polycystic Ovarian Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture protocol 1

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.

Group Type ACTIVE_COMPARATOR

acupuncture protocol 1

Intervention Type 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.

Acupuncture protocol 2

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.

Group Type SHAM_COMPARATOR

Acupuncture protocol 2

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture protocol 1

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

Acupuncture protocol 2

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

real acupuncture sham acupuncture

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No