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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Efficacy of Acupunture on Menstrual Frequency in Women With Polycystic Ovary Syndrome: Protocol for a Randomized, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02653911
• Other study ID #: 2015EC115
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: June 2022

Study information

• Verified date: September 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jing Zhou, Master
• Phone: 86-15650729586
• Email: zjinbj[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Acupuncture
Hwato Brand, Suzhou Medical Appliance Factory, China
• Sham-acupuncture group
Hwato Brand, Suzhou Medical Appliance Factory, China

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding assessment	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".	Months 3
Other	Expectation value of the acupuncture effect assessment	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".	Baseline
Other	Safety assessment	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.	The whole process
Primary	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	Change in menstrual frequency	The proportion of participants who have at least a 50% increase from baseline in monthly menstrual frequency	Months 6
Secondary	The change in measurements for body mass index (BMI) from baseline	Change in anthropometry	Months 3 and 6
Secondary	The change in measurements for waist-hip ratio (WHR) from baseline	Change in anthropometry	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	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.	Months 3 and 6
Secondary	The change in mean difference in ovary volume from baseline	Change in ovarian morphology	Months 3 and 6
Secondary	The change in thickness of the endometrium from baseline	Change in ovarian morphology	Months 3 and 6
Secondary	The change in the number of follicles <9 mm from baseline	Change in ovarian morphology	Months 3 and 6
Secondary	Change in hirsutism	The change in Ferriman-Gallwey (FG) score from baseline	Months 3 and 6
Secondary	Change in acne	The change in Global Acne Grading System (GAGS) from baseline	Months 3 and 6
Secondary	Change in anxiety and depression	The change in The score of the Hospital Anxiety and Depression Scale (HADS) from baseline	Months 3 and 6
Secondary	Change in quality of life	The change in Polycystic Ovary Syndrome Questionnaire (PCOSQ) scores from baseline	Months 3 and 6