Electroacupuncture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Study Protocol

Guang'anmen Hospital of China Academy of Chinese Medical Sciences172 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Polycystic Ovary Syndrome

Interventions

AcupunctureOTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

Sham-acupuncture groupOTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Months 3

Secondary Outcomes

Change in menstrual frequency

The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency

Time frame: Months 6

The change in measurements for body mass index (BMI) from baseline

Change in anthropometry

Time frame: Months 3 and 6

The change in measurements for waist-hip ratio (WHR) from baseline

Change in anthropometry

Time frame: 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.

Time frame: 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.

Time frame: Months 3 and 6

The change in LH/FSH ratio from baseline

Central Contacts

Jing Zhou, Master

CONTACT

86-15650729586 zjinbj@sina.com

Data from ClinicalTrials.gov

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