Polycystic Ovary SyndromeNCT01812161
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
A study testing acupuncture protocol 1 and Acupuncture protocol 2 in people with Polycystic Ovary Syndrome, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 28 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- acupuncture protocol 1 and Acupuncture protocol 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
Wuhan, Hubei, 027
About this study
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- acupuncture protocol 1, Acupuncture protocol 2
- Keywords
- Electro-acupuncture, HCG stimulation test, Menstrual frequency, polycystic ovary syndrome, Randomized, controlled, trial
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture protocol 1Other
Also called real acupuncture
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 2Other
Also called sham acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Acupuncture protocol 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (6)
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 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.
Measured: 16 weeks
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.
Measured: 16 weeks
serum levels of the neurotransmitter
serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Heilongjiang University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, The University of Hong Kong
- Responsible party
- Principal investigator, Dongmei Huang, Huazhong University of Science and Technology
- Investigators
- Dongmei Huang, doctor, Principal investigator, Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812161
- Sponsor's protocol ID
- 15002738313766868351
- Status last verified
- Feb 2018
- First submitted
- 24 Dec 2012
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: we use the Clinical Trial Management Public Platform to manage and share our date.
Publications
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.
PubMed 20943753Dong 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.
PubMed 34319506Wang 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.
PubMed 30843421
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01812161
- Acronym / sponsor ID
- 15002738313766868351
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Electro-acupuncture, HCG stimulation test, Menstrual frequency, polycystic ovary syndrome, Randomized, controlled, trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Heilongjiang University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, The University of Hong Kong
- Study start
- Nov 2012 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture protocol 1 | Active comparator | Other: acupuncture protocol 1Acupuncture 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 | Sham comparator | Other: Acupuncture protocol 2Acupuncture 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture protocol 1Also: real acupunctureDisposable, 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. | Other | Acupuncture protocol 1 |
| Acupuncture protocol 2Also: sham acupunctureDisposable, 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. | Other | Acupuncture protocol 2 |
Primary outcome
HCG stimulation test
Time frame: 16 weeks
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.
6 secondary outcomes
Laboratory examination
Time frame: 16 weeks
trans-abdomen ultrasound of the uterus and ovaries
Time frame: 16 weeks
Physical examination
Time frame: 16 weeks
Number of Participants with Adverse Events
Time frame: 16 weeks
menstrual frequency
Time frame: 16 weeks
serum levels of the neurotransmitter
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Background: PubMed 20943753Jedel 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.
- Derived from this study: PubMed 34319506Dong 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.
- Derived from this study: PubMed 30843421Wang 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.
- Individual participant dataSharing planned: Yes. we use the Clinical Trial Management Public Platform to manage and share our date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongmei Huang, doctor principal investigator
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture protocol 1 and Acupuncture protocol 2 in people with Polycystic Ovary Syndrome, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCG stimulation test (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812161, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.