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

NCT ID: NCT02653911

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-06-30

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

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.

Group Type: SHAM_COMPARATOR

Sham-acupuncture group

Intervention Type: OTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

Interventions

Acupuncture

Hwato Brand, Suzhou Medical Appliance Factory, China

Intervention Type: OTHER

Sham-acupuncture group

Hwato Brand, Suzhou Medical Appliance Factory, China

Intervention Type: OTHER

Other Intervention Names

Placebo needle

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zhou Jing

Department of Acupuncture, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu, Ph D

Role: STUDY_DIRECTOR

Guang Am Men Hospital,China Academy of Chinese Medical Sciences

Central Contacts

Jing Zhou, Master

Role: CONTACT

zjinbj@sina.com

86-15650729586

Other Identifiers

2015EC115

Identifier Type: -

Identifier Source: org_study_id