Back to resultsElectroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sham-acupuncture group
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Acupuncture
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
acupuncture group
Sham-acupuncture group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in menstrual frequency
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
The change in measurements for body mass index (BMI) from baseline
Change in anthropometry
The change in measurements for waist-hip ratio (WHR) from baseline
Change in anthropometry
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The change in mean difference in ovary volume from baseline
Change in ovarian morphology
The change in thickness of the endometrium from baseline
Change in ovarian morphology
The change in the number of follicles <9 mm from baseline
Change in ovarian morphology
Change in hirsutism
The change in Ferriman-Gallwey (FG) score from baseline
Change in acne
The change in Global Acne Grading System (GAGS) from baseline
Change in anxiety and depression
The change in The score of the Hospital Anxiety and Depression Scale (HADS) from baseline
Change in quality of life
The change in Polycystic Ovary Syndrome Questionnaire (PCOSQ) scores from baseline
Full Information
NCT ID
NCT02653911
First Posted
January 3, 2016
Last Updated
September 6, 2020
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02653911
Brief Title
Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol
Official Title
Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-acupuncture group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Hwato Brand, Suzhou Medical Appliance Factory, China
Intervention Type
Other
Intervention Name(s)
Sham-acupuncture group
Other Intervention Name(s)
Placebo needle
Intervention Description
Hwato Brand, Suzhou Medical Appliance Factory, China
Primary Outcome Measure Information:
Title
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
Description
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.
Time Frame
Months 3
Secondary Outcome Measure Information:
Title
Change in menstrual frequency
Description
The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
Time Frame
Months 6
Title
The change in measurements for body mass index (BMI) from baseline
Description
Change in anthropometry
Time Frame
Months 3 and 6
Title
The change in measurements for waist-hip ratio (WHR) from baseline
Description
Change in anthropometry
Time Frame
Months 3 and 6
Title
The change in serum luteinizing hormone (LH) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in follicle stimulating hormone (FSH) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in LH/FSH ratio from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in testosterone (T) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in estrogen (E) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in prolactin (PRL) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in progesterone (Prog) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in dehydroepiandrosterone (DHEA) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in sex-hormone binding globulin (SHBG) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in androstenedione (AND) from baseline
Description
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.
Time Frame
Months 3 and 6
Title
The change in mean difference in ovary volume from baseline
Description
Change in ovarian morphology
Time Frame
Months 3 and 6
Title
The change in thickness of the endometrium from baseline
Description
Change in ovarian morphology
Time Frame
Months 3 and 6
Title
The change in the number of follicles <9 mm from baseline
Description
Change in ovarian morphology
Time Frame
Months 3 and 6
Title
Change in hirsutism
Description
The change in Ferriman-Gallwey (FG) score from baseline
Time Frame
Months 3 and 6
Title
Change in acne
Description
The change in Global Acne Grading System (GAGS) from baseline
Time Frame
Months 3 and 6
Title
Change in anxiety and depression
Description
The change in The score of the Hospital Anxiety and Depression Scale (HADS) from baseline
Time Frame
Months 3 and 6
Title
Change in quality of life
Description
The change in Polycystic Ovary Syndrome Questionnaire (PCOSQ) scores from baseline
Time Frame
Months 3 and 6
Other Pre-specified Outcome Measures:
Title
Blinding assessment
Description
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".
Time Frame
Months 3
Title
Expectation value of the acupuncture effect assessment
Description
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".
Time Frame
Baseline
Title
Safety assessment
Description
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.
Time Frame
The whole process
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhou, Master
Phone
86-15650729586
Email
zjinbj@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, Ph D
Organizational Affiliation
Guang Am Men Hospital,China Academy of Chinese Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol
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