Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Biochemical pregnancy
研究概览
简要总结
The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.
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 aged from 18 to 35
- •Infertility for a period of a year or more or 6 month of irregular menstrual cycle
- •PCOS under the Rotterdam criteria
- •Insulin resistance HOMA-IR > 2.5
- •Normal semen analysis values
- •Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test
排除标准
- •Tubular factor
- •Normal ovarian reserve
- •Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
- •Neoplasia
- •BMI > 35
- •Renal, hepatic or cardiac failure
- •Lactic, acidosis antecedent
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Clomiphene Citrate
干预措施: Clomiphene citrate (Drug)
结局指标
主要结局
Biochemical pregnancy
时间窗: 1 month
Rate of biochemical pregnancy
次要结局
- Ovulation rate(1 month)
- BMI and waist size changing(6 months)
- Live birth rate(6 months)
- AMH correlation/variation in function of Metformin(6 months)
- Spontaneous abortion rate(6 months)
- Insulin resistance changing(6 months)