Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Changes in ovarian stromal blood flow by using Doppler
研究概览
简要总结
This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with PCOS according to the Rotterdam criteria
排除标准
- •Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- •Medical or surgical treatment of PCOS during the previous 3 months
- •Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- •Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
- •Inability to understand the proposal of the study precluding effective informed consent
研究组 & 干预措施
Metformin
Metformin 500mg bid in morning and evening after meals to be taken for 6 months.
干预措施: Metformin Hydrochloride (Drug)
OCP
OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.
干预措施: Ethinyl Estradiol-cyprosterone acetate (Drug)
结局指标
主要结局
Changes in ovarian stromal blood flow by using Doppler
时间窗: 6 months
By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.
次要结局
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(6 months)
- Change in BMI as measured in kg/m2(6 months)
- Improvement in hirsutism measured by Modified Ferriman and Gallwey scores(6 months)
- Improvement in menstrual cycle pattern(6 months)
- Change in waist circumference (cm)(6 months)
- Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)(6 months)
- Change in blood level of Testosterone (nmol/L)(6 months)
- Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)(6 months)
- Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)(6 months)
- Changes in fasting serum insulin levels (mIU/L)(6 months)
- Changes in fasting serum glucose levels (mg/dL)(6 months)