Polycystic Ovary SyndromeNCT02653911
Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol
A study testing Acupuncture in people with Polycystic Ovary Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical manifestations of PCOS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jun 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants fulfilling any one of the following criteria will be excluded. Participants who fulfill the following criteria will be included.
- Participants meet the Rotterdam diagnostic criteria with oligomenorrhea or amenorrhea. (Oligomenorrhoea is defined as an intermenstrual interval of >35 days or <8 menstrual bleedings in the past year. Amenorrhoea is defined as absent menstrual bleeding or no menstrual bleeding in the previous 90 days.)
- Participants who have at least two of the following features that meet the Rotterdam diagnostic criteria:
- Clinical or biochemical hyperandrogenism: Biochemical hyperandrogenaemia is defined as a total serum testosterone concentration above normal threshold, and/or clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score of ≥5 or acne defined by the Global Acne Grading System (GAGS) as "mild"/ "moderate"/ "severe"/ "very severe".
- Polycystic ovary morphology is defined as the presence of ≥12 follicles in each ovary measuring 2-9 mm in diameter and/or an ovarian volume >10 mL on transvaginal ultrasound.
- Participants who are between 18 to 40 years old.
- Participants who joined the research and provided a signed informed consent voluntarily.
Who cannot join
- Participants with fertility requirements.
- Participants with oligomenorrhea or amenorrhea caused by hyperandrogenemia, premature ovarian failure, or hypothalamus or pituitary disorders.
- Participants with hyperandrogenism caused by congenital adrenal hyperplasia, Cushing's syndrome and androgen-secreting tumors.
- Participants with endocrine disorders such as thyroid dysfunction, adrenal disorders, hyperprolactinemia and diabetes mellitus.
- Participants with severe heart disease, hepatic disease, renal system and hematopoietic system disease, or malnutrition of the whole body.
- Participants who use hormones or other medications that would affect reproductive function, or received the same protocol of this study in the past three months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial
Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical manifestations of PCOS. The aim of this study is to evaluate the efficacy of acupuncture in improving the menstrual frequency of PCOS patients who do not have fertility requirements.
Read the detailed description
Methods: A total of 172 participants diagnosed with polycystic ovary syndrome would be randomly assigned to either the acupuncture group or sham-acupuncture group, at a ratio of 1:1. Participants in both groups will receive treatment for 12 weeks, three times a week. The primary outcome will be the proportion of participants with at least a 50% increase from baseline in the monthly menstrual frequency from baseline after 12 weeks intervention, while secondary outcomes will be the difference in anthropometrics, serum hormone level, ovarian morphology, anxiety and depression, and quality of life from baseline to after 12 weeks intervention and to 12 weeks post-intervention follow-up between groups.
Discussion The aim of this study is to evaluate the efficacy and safety of acupuncture for improving menstrual frequency and other symptoms of patients with PCOS. The limitation of this trial is that it would be difficult to blind the acupuncturists. Additionally, these findings may not be suitable for women with PCOS who are seeking pregnancy.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Acupuncture, Sham-acupuncture group
- Keywords
- Acupuncture
- 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.
AcupunctureOther
Hwato Brand, Suzhou Medical Appliance Factory, China
Sham-acupuncture groupOther
Also called Placebo needle
Hwato Brand, Suzhou Medical Appliance Factory, China
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Bilateral ST25, EX-CA1, CV4 and SP6 will be selected for treatment. After routine sterilization of the local skin, bilateral ST25, EX-CA1, CV4 and SP 6 will be inserted by the needles (0.30 mm in diameter, 40 mm in length) to a depth of 25-30 mm to the abdominal muscle layer with the manipulation of lifting, thrusting and rotating until "de qi". Each session will last for 30 minutes, and the manipulation of lifting, thrusting and rotating evenly three times will be used for CV 4 and SP 6 every 10 minutes. If the date of treatment is during the menstrual circle, the treatment will be continued as usual. Participants will be treated three times a week for 12 weeks with 36 sessions. Receives: Other: Acupuncture |
| Sham-acupuncture group | Sham comparator | The sham ST25, EX-CA1, CV4 and SP 6, which are 1 cun (25 mm) outward to ST25, EX-CA1, CV4 and SP 6, will be inserted to 2-3 mm with needles with a diameter of 0.30 mm and a length of 13 mm. The needles will be inserted without de qi or any manipulation. The treatment sessions will be the same as those in the acupuncture group. Receives: Other: Sham-acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
Baseline monthly menstrual frequency was calculated through the number of menstrual bleeds in three months before intervention divided by three. Monthly menstrual frequency from baseline to three months was calculated through the number of menstrual bleeds during the three month-intervention divided by three.
Measured: Months 3
Secondary outcomes (20)
Change in menstrual frequency
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
Measured: Months 6
The change in measurements for body mass index (BMI) from baseline
Change in anthropometry
Measured: Months 3 and 6
The change in measurements for waist-hip ratio (WHR) from baseline
Change in anthropometry
Measured: Months 3 and 6
The change in serum luteinizing hormone (LH) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in follicle stimulating hormone (FSH) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in LH/FSH ratio from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in testosterone (T) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in estrogen (E) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in prolactin (PRL) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in progesterone (Prog) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in dehydroepiandrosterone (DHEA) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in sex-hormone binding globulin (SHBG) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in androstenedione (AND) from baseline
Blood samples will be taken at menstrual cycle days 2-4 when ovulation or bleeding occurs. Otherwise, this will be performed on the arbitrary day of the cycle.
Measured: Months 3 and 6
The change in mean difference in ovary volume from baseline
Change in ovarian morphology
Measured: Months 3 and 6
The change in thickness of the endometrium from baseline
Change in ovarian morphology
Measured: Months 3 and 6
The change in the number of follicles <9 mm from baseline
Change in ovarian morphology
Measured: Months 3 and 6
Change in hirsutism
The change in Ferriman-Gallwey (FG) score from baseline
Measured: Months 3 and 6
Change in acne
The change in Global Acne Grading System (GAGS) from baseline
Measured: Months 3 and 6
Change in anxiety and depression
The change in The score of the Hospital Anxiety and Depression Scale (HADS) from baseline
Measured: Months 3 and 6
Change in quality of life
The change in Polycystic Ovary Syndrome Questionnaire (PCOSQ) scores from baseline
Measured: Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Jing, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Ph D, Study director, Guang Am Men Hospital,China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653911
- Sponsor's protocol ID
- 2015EC115
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02653911
- Acronym / sponsor ID
- 2015EC115
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Jan 2016 (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.
Polycystic ovary syndrome (PCOS) is a dysfunction of endocrine system of women of reproductive age. Approximately 5%-10% women in China have this syndrome. Irregular menstruation (oligomenorrhea or amenorrhea), hirsutism and obesity are the common clinical manifestations of PCOS. The aim of this study is to evaluate the efficacy of acupuncture in improving the menstrual frequency of PCOS patients who do not have fertility requirements.
Detailed description
Methods: A total of 172 participants diagnosed with polycystic ovary syndrome would be randomly assigned to either the acupuncture group or sham-acupuncture group, at a ratio of 1:1. Participants in both groups will receive treatment for 12 weeks, three times a week. The primary outcome will be the proportion of participants with at least a 50% increase from baseline in the monthly menstrual frequency from baseline after 12 weeks intervention, while secondary outcomes will be the difference in anthropometrics, serum hormone level, ovarian morphology, anxiety and depression, and quality of life from baseline to after 12 weeks intervention and to 12 weeks post-intervention follow-up between groups.
Discussion The aim of this study is to evaluate the efficacy and safety of acupuncture for improving menstrual frequency and other symptoms of patients with PCOS. The limitation of this trial is that it would be difficult to blind the acupuncturists. Additionally, these findings may not be suitable for women with PCOS who are seeking pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Other: AcupunctureBilateral ST25, EX-CA1, CV4 and SP6 will be selected for treatment. After routine sterilization of the local skin, bilateral ST25, EX-CA1, CV4 and SP 6 will be inserted by the needles (0.30 mm in diameter, 40 mm in length) to a depth of 25-30 mm to the abdominal muscle layer with the manipulation of lifting, thrusting and rotating until "de qi". Each session will last for 30 minutes, and the manipulation of lifting, thrusting and rotating evenly three times will be used for CV 4 and SP 6 every 10 minutes. If the date of treatment is during the menstrual circle, the treatment will be continued as usual. Participants will be treated three times a week for 12 weeks with 36 sessions. |
| Sham-acupuncture group | Sham comparator | Other: Sham-acupuncture groupThe sham ST25, EX-CA1, CV4 and SP 6, which are 1 cun (25 mm) outward to ST25, EX-CA1, CV4 and SP 6, will be inserted to 2-3 mm with needles with a diameter of 0.30 mm and a length of 13 mm. The needles will be inserted without de qi or any manipulation. The treatment sessions will be the same as those in the acupuncture group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants fulfilling any one of the following criteria will be excluded. Participants who fulfill the following criteria will be included.
- Participants meet the Rotterdam diagnostic criteria with oligomenorrhea or amenorrhea. (Oligomenorrhoea is defined as an intermenstrual interval of >35 days or <8 menstrual bleedings in the past year. Amenorrhoea is defined as absent menstrual bleeding or no menstrual bleeding in the previous 90 days.)
- Participants who have at least two of the following features that meet the Rotterdam diagnostic criteria:
- Participants who are between 18 to 40 years old.
- Participants who joined the research and provided a signed informed consent voluntarily.
Key exclusion criteria (6 listed)
- Participants with fertility requirements.
- Participants with oligomenorrhea or amenorrhea caused by hyperandrogenemia, premature ovarian failure, or hypothalamus or pituitary disorders.
- Participants with hyperandrogenism caused by congenital adrenal hyperplasia, Cushing's syndrome and androgen-secreting tumors.
- Participants with endocrine disorders such as thyroid dysfunction, adrenal disorders, hyperprolactinemia and diabetes mellitus.
- Participants with severe heart disease, hepatic disease, renal system and hematopoietic system disease, or malnutrition of the whole body.
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 |
|---|---|---|
| AcupunctureHwato Brand, Suzhou Medical Appliance Factory, China | Other | acupuncture group |
| Sham-acupuncture groupAlso: Placebo needleHwato Brand, Suzhou Medical Appliance Factory, China | Other | Sham-acupuncture group |
Primary outcome
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
Time frame: Months 3
Baseline monthly menstrual frequency was calculated through the number of menstrual bleeds in three months before intervention divided by three. Monthly menstrual frequency from baseline to three months was calculated through the number of menstrual bleeds during the three month-intervention divided by three.
20 secondary outcomes
Change in menstrual frequency
Time frame: Months 6
The change in measurements for body mass index (BMI) from baseline
Time frame: Months 3 and 6
The change in measurements for waist-hip ratio (WHR) from baseline
Time frame: Months 3 and 6
The change in serum luteinizing hormone (LH) from baseline
Time frame: Months 3 and 6
The change in follicle stimulating hormone (FSH) from baseline
Time frame: Months 3 and 6
The change in LH/FSH ratio from baseline
Time frame: Months 3 and 6
The change in testosterone (T) from baseline
Time frame: Months 3 and 6
The change in estrogen (E) from baseline
Time frame: Months 3 and 6
The change in prolactin (PRL) from baseline
Time frame: Months 3 and 6
The change in progesterone (Prog) from baseline
Time frame: Months 3 and 6
The change in dehydroepiandrosterone (DHEA) from baseline
Time frame: Months 3 and 6
The change in sex-hormone binding globulin (SHBG) from baseline
Time frame: Months 3 and 6
The change in androstenedione (AND) from baseline
Time frame: Months 3 and 6
The change in mean difference in ovary volume from baseline
Time frame: Months 3 and 6
The change in thickness of the endometrium from baseline
Time frame: Months 3 and 6
The change in the number of follicles <9 mm from baseline
Time frame: Months 3 and 6
Change in hirsutism
Time frame: Months 3 and 6
Change in acne
Time frame: Months 3 and 6
Change in anxiety and depression
Time frame: Months 3 and 6
Change in quality of life
Time frame: Months 3 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Zhishun Liu, Ph D study director
Guang Am Men Hospital,China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Polycystic Ovary Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhou, Master (86-15650729586, zjinbj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency (time frame: Months 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.