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

NCT02653911 | Unknown DMC

• 1 other identifier: 2015EC115
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  Months 3

Secondary Outcomes (20)

• Change in menstrual frequency

  Months 6

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

  Months 3 and 6

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

  Months 3 and 6

• The change in serum luteinizing hormone (LH) from baseline

  Months 3 and 6

• The change in follicle stimulating hormone (FSH) from baseline

  Months 3 and 6

Other Outcomes (3)

• Blinding assessment

  Months 3

• Expectation value of the acupuncture effect assessment

  Baseline

• Safety assessment

  The whole process

Study Arms (2)

acupuncture group

EXPERIMENTAL

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.

Other: Acupuncture

Sham-acupuncture group

SHAM COMPARATOR

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.

Other: Sham-acupuncture group

Interventions

Acupuncture OTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

acupuncture group

Sham-acupuncture group OTHER

Hwato Brand, Suzhou Medical Appliance Factory, China

Also known as: Placebo needle

Sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhishun Liu, Ph D

  Guang Am Men Hospital,China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Jing Zhou, Master

CONTACT

86-15650729586; zjinbj@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Acupuncture, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 13, 2016
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share