A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- the level of body fat distribution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCOS according to the 2003 Rotterdam criteria with at least two of the following three symptoms: clinical and/or biochemical signs of hyperandrogenism (hirsutism or acne), oligomerism/amenorrhea, and/or polycystic ovaries (PCOS). Biochemical hyperandrogenism is defined as total testosterone > 2.6 nmol/L or free androgen index >
- •Hirsutism is defined as an FG score ≥
- •Oligomenorrhea is defined as menstrual bleeding > 35 days between menstrual periods in the past year, < 8 menstrual bleeding. Amenorrhea is < 3 cycles per year. PCO is defined by transvaginal ultrasound, where one or both ovaries ≥ 12 follicles 2-9 mm and/or ovarian volume ≥ 10 mL. Other endocrine disorders such as atypical congenital adrenal hyperplasia (17-hydroxyprogesterone <3 nmol/L), androgen-secreting tumors, or suspected Cushing syndrome are excluded.
- •Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
- •PCOS patients: BMI ≥ 25 to ≤40kg/m
- •Willing to sign the consent form.
排除标准
- •History of severe heart disease, hematologic disease;
- •Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;
- •Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
- •Type I diabetes mellitus;
- •Medication within 12 weeks (hormonal drugs, antidepressants, other anti-diabetic drugs, contraceptives, ovulation induction drugs or other drugs that affect the trial in the judgment of the investigator);
- •Allergy to metformin hydrochloride or any excipients;
- •Blood pressure > 160/100 mm Hg;
- •Pregnancy or breastfeeding in the past three months;
- •No history of acupuncture treatment within 2 months;
- •Alcohol dependence
- •Persons with disabilities with language impairment or reduced ability to understand the information provided;
- •Those who have participated in other clinical studies within three months;
- •The man clearly diagnoses infertility-related diseases and factors.
研究组 & 干预措施
acupuncture+ intensive lifestyle intervention
8 weeks acupuncture+ intensive lifestyle intervention
干预措施: Acupuncture+lifestyle intervention (Other)
metformin + intensive lifestyle intervention
8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention
干预措施: Metformin+lifestyle intervention (Other)
结局指标
主要结局
the level of body fat distribution
时间窗: up to 8 weeks
Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome
Pregnancy rates after intervention
时间窗: up to 1 year
Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome
Body mass index
时间窗: up to 8 weeks
Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.
次要结局
- Standardized TCM syndrome differentiation and classification of PCOS patients(up to 8 weeks)
- Glucose metabolism(up to 8 weeks)
- Female menstrual pattern(up to 8 weeks)
- Intestinal bacteria microbiota(up to 8 weeks)