Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and is characterized by ovulatory dysfunction, increased androgens, and polycystic ovaries. The goal of this randomized control study is to compare the efficacy between acupuncture and metformin both with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rates improvement.
A randomized control study is designed to compare the efficacy of acupuncture and metformin with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rate improvement. 92 patients will be enrolled from Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine and will be divided into 2 groups: acupuncture+ intensive lifestyle intervention group and metformin + intensive lifestyle intervention group. Each group used a specific treatment (shown as the group name) for 8 weeks. In this study, the role of acupuncture in improving weight control and pregnancy rate in overweight/obese PCOS patients will be evaluated, the safety and efficacy of acupuncture as well as metabolic measurements. Molecular targets and models for predicting the sensitivity and prognosis of acupuncture treatment, as well as in-depth research on the molecular mechanism of acupuncture in treating PCOS, have a guiding significance and promote the modernization of traditional medicine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
8 weeks Acupuncture treatment for 2-3 times/week, 30min each time and lifestyle intervention((1) Daily intake of 1200\~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)
8 weeks Metformin 500 mg three times a day with meals and lifestyle intervention ((1) Daily intake of 1200\~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
the level of body fat distribution
Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome
Time frame: up to 8 weeks
Pregnancy rates after intervention
Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome
Time frame: up to 1 year
Body mass index
Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.
Time frame: up to 8 weeks
Standardized TCM syndrome differentiation and classification of PCOS patients
Through the "tongue and pulse image, meridians, and constitution identification collection analyzer" (registration certificate number: Ji Machinery Note 20202200354), the standardized TCM syndrome differentiation and classification of PCOS patients was clarified.
Time frame: up to 8 weeks
Glucose metabolism
the area under the curve (AUC insulin), fasting insulin, glucose, computational homeostatic model assessment (HOMA)-IR and HOMA-B (i.e., isis β cell function) were calculated during the insulin-to-glucose tolerance test (OGTT)
Time frame: up to 8 weeks
Female menstrual pattern
Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement
Time frame: up to 8 weeks
Intestinal bacteria microbiota
Such measurement is tested through gene and microbiota testing. Those who have taken antibiotics and live bacteria within one week are excluded.
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Time frame: up to 8 weeks