NCT06306417已完成不适用
Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- HOMA-IR
研究概览
简要总结
To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.
详细描述
A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups.
- To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS;
- To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL
排除标准
- •Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia.
- •Type I diabetes or not well controlled type II diabetes
- •Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
- •Psychiatric diagnoses or using psychiatric medications including antidepressants
- •Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
结局指标
主要结局
HOMA-IR
时间窗: baseline and after 4 months
calculation of HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5) \[Time Frame: Baseline\]
次要结局
- Prolactin (PRL)(baseline and after 4 months)
- Progestin (P)(baseline and after 4 months)
- high density lipoprotein (HDL)(baseline and after 4 months)
- low density lipoprotein (LDL)(baseline and after 4 months)
- waist to hip ratio(WHR)(baseline and after 4 months)
- glycosylated hemoglobin level(baseline and after 4 months)
- Follicle stimulating hormone (FSH)(baseline and after 4 months)
- luteinizing hormone (LH)(baseline and after 4 months)
- Estrogen (E2)(baseline and after 4 months)
- Free testosterone index (FAI)(baseline and after treatment)
- number of follicles(baseline and after 4 months)
- total cholesterol(baseline and after 4 months)
- AUC insulin(baseline and after 4 months)
- Bile acidomics(baseline and after 4 months)
- polycystic ovary syndrome questionnaire, PCOSQ(baseline and after 4 months)
- uterine size(baseline and after 4 months)
- Hirsutism(FG score >4）, acne and early alopecia(baseline and after 4 months)
- Androgen(T)(baseline and after 4 months)
- Anti-mullerian hormone (AMH)(baseline and after 4 months)
- Sex hormone-binding globulin (SHBG)(baseline and after 4 months)
- Self-Rating Anxiety Scale (SAS)(baseline and after 4 months)
- Self-Rating Depress Scale (SDS)(baseline and after 4 months)
- triglycerides(baseline and after 4 months)
- Metagenomics and 16S rDNA sequencing analysis(baseline and after 4 months)
- short form-36 (SF36)(baseline and after 4 months)
- BMI(baseline and after 4 months)
- ovarian size(baseline and after 4 months)
- Fat%(baseline and after 4 months)
- endometrial thickness(baseline and after 4 months)
研究者
研究点 (1)
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