Clinical trial NCT02653911: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Acupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  1. 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".
  2. 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.

Primary outcomes:
measure: The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency
timeFrame: Months 3
Secondary outcomes:
measure: Change in menstrual frequency
timeFrame: Months 6
measure: The change in measurements for body mass index (BMI) from baseline
timeFrame: Months 3 and 6
measure: The change in measurements for waist-hip ratio (WHR) from baseline
timeFrame: Months 3 and 6
measure: The change in serum luteinizing hormone (LH) from baseline
timeFrame: Months 3 and 6
measure: The change in follicle stimulating hormone (FSH) from baseline
timeFrame: Months 3 and 6
measure: The change in LH/FSH ratio from baseline
timeFrame: Months 3 and 6
measure: The change in testosterone (T) from baseline
timeFrame: Months 3 and 6
measure: The change in estrogen (E) from baseline
timeFrame: Months 3 and 6
measure: The change in prolactin (PRL) from baseline
timeFrame: Months 3 and 6
measure: The change in progesterone (Prog) from baseline
timeFrame: Months 3 and 6
measure: The change in dehydroepiandrosterone (DHEA) from baseline
timeFrame: Months 3 and 6
measure: The change in sex-hormone binding globulin (SHBG) from baseline
timeFrame: Months 3 and 6
measure: The change in androstenedione (AND) from baseline
timeFrame: Months 3 and 6
measure: The change in mean difference in ovary volume from baseline
timeFrame: Months 3 and 6
measure: The change in thickness of the endometrium from baseline
timeFrame: Months 3 and 6
measure: The change in the number of follicles <9 mm from baseline
timeFrame: Months 3 and 6
measure: Change in hirsutism
timeFrame: Months 3 and 6
measure: Change in acne
timeFrame: Months 3 and 6
measure: Change in anxiety and depression
timeFrame: Months 3 and 6
measure: Change in quality of life
timeFrame: Months 3 and 6
Other outcomes:
measure: Blinding assessment
timeFrame: Months 3
measure: Expectation value of the acupuncture effect assessment
timeFrame: Baseline
measure: Safety assessment
timeFrame: The whole process
Locations:
Study officials:
affiliation: Guang Am Men Hospital,China Academy of Chinese Medical Sciences
name: Zhishun Liu, Ph D
role: STUDY_DIRECTOR
References: