- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02653911
Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol
Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jing Zhou, Master
- Phone Number: 86-15650729586
- Email: zjinbj@sina.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acupuncture group
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.
|
Hwato Brand, Suzhou Medical Appliance Factory, China
|
Sham Comparator: Sham-acupuncture group
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.
|
Hwato Brand, Suzhou Medical Appliance Factory, China
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Months 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in menstrual frequency
Time Frame: Months 6
|
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
|
Months 6
|
The change in measurements for body mass index (BMI) from baseline
Time Frame: Months 3 and 6
|
Change in anthropometry
|
Months 3 and 6
|
The change in measurements for waist-hip ratio (WHR) from baseline
Time Frame: Months 3 and 6
|
Change in anthropometry
|
Months 3 and 6
|
The change in serum luteinizing hormone (LH) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in follicle stimulating hormone (FSH) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in LH/FSH ratio from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in testosterone (T) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in estrogen (E) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in prolactin (PRL) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in progesterone (Prog) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in dehydroepiandrosterone (DHEA) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in sex-hormone binding globulin (SHBG) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in androstenedione (AND) from baseline
Time Frame: Months 3 and 6
|
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.
|
Months 3 and 6
|
The change in mean difference in ovary volume from baseline
Time Frame: Months 3 and 6
|
Change in ovarian morphology
|
Months 3 and 6
|
The change in thickness of the endometrium from baseline
Time Frame: Months 3 and 6
|
Change in ovarian morphology
|
Months 3 and 6
|
The change in the number of follicles <9 mm from baseline
Time Frame: Months 3 and 6
|
Change in ovarian morphology
|
Months 3 and 6
|
Change in hirsutism
Time Frame: Months 3 and 6
|
The change in Ferriman-Gallwey (FG) score from baseline
|
Months 3 and 6
|
Change in acne
Time Frame: Months 3 and 6
|
The change in Global Acne Grading System (GAGS) from baseline
|
Months 3 and 6
|
Change in anxiety and depression
Time Frame: Months 3 and 6
|
The change in The score of the Hospital Anxiety and Depression Scale (HADS) from baseline
|
Months 3 and 6
|
Change in quality of life
Time Frame: Months 3 and 6
|
The change in Polycystic Ovary Syndrome Questionnaire (PCOSQ) scores from baseline
|
Months 3 and 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blinding assessment
Time Frame: Months 3
|
Participants will answer the following questions after 12 weeks of intervention, in order to assess the blinding: "Do you think you have received traditional acupuncture in the past weeks?"
The participants can answer "Yes", "No" or "Unclear".
|
Months 3
|
Expectation value of the acupuncture effect assessment
Time Frame: Baseline
|
Participants will answer the following questions before the intervention: "Do you think acupuncture will be effective for treating the disease?" "Do you think acupuncture will be effective for improving the related symptoms of PCOS?"
The participants can answer "Yes", "No" or "Unclear".
|
Baseline
|
Safety assessment
Time Frame: The whole process
|
All adverse reactions will be presented in tables with a description on the categories, severity, rate of incidence, and correlation with the treatment.
Adverse reactions related to acupuncture (severe pain, local hematoma, infection and abscess, and retained needle and broken needle during the treatment), including some discomforts after treatment, will be recorded in time in detail.
Adverse events irrelevant with the treatment will also be recorded in detail.
|
The whole process
|
Collaborators and Investigators
Investigators
- Study Director: Zhishun Liu, Ph D, Guang Am Men Hospital,China Academy of Chinese Medical Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015EC115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycystic Ovary Syndrome
-
Cairo UniversityCompleted
-
Alexandria UniversityRecruitingPolycystic Ovary Syndrome (PCOS)Egypt
-
Saudi German Hospital - MadinahCompletedPolycystic Ovary Syndrome (PCOS)Saudi Arabia
-
University of CopenhagenCompletedPolycystic Ovary Syndrome (PCOS)Denmark
-
Odense University HospitalCompleted
-
Assaf-Harofeh Medical CenterUnknownInfertility | Polycystic OvariesIsrael
-
Poznan University of Medical SciencesUniversity of California, DavisUnknownPolycystic Ovary Syndrome (PCOS)Poland
-
Riphah International UniversityCompleted
-
Dexa Medica GroupCompletedPolycystic Ovary Syndrome (PCOS)Indonesia
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPolycystic Ovary Syndrome (PCOS)United States
Clinical Trials on Acupuncture
-
Federal University of São PauloCompleted
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting