Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Ovulation rate
研究概览
简要总结
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).
详细描述
Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile lean women with PCOS as defined by the Rotterdam criteria.
- •CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
排除标准
- •Age < 20 or > 35 years.
- •Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m
- •Presence of any infertility factor other than anovulatory PCOS.
- •Previous history of ovarian surgery or surgical removal of one ovary.
- •Previous exposure to cytotoxic drugs or pelvic irradiation.
- •Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- •Metabolic or hormonal abnormalities
研究组 & 干预措施
Clomiphene citrate-Prednisolone group
Women will receive clomiphene citrate and prednisolone
干预措施: Clomiphene citrate and Prednisolone (Drug)
Clomiphene citrate-placebo group
Women will receive clomiphene citrate and folic acid 0.5mg (placebo)
干预措施: Clomiphene citrate and folic acid (Drug)
结局指标
主要结局
Ovulation rate
时间窗: 3 months
Number of ovulatory cycles divided by the number of stimulation cycles
次要结局
- Number of ovarian follicles ≥ 18 mm on day of HCG administration(3 months)
- Endometrial thickness on day of HCG administration(3 months)
- Clinical pregnancy rate(6-8 weeks gestational age)
研究者
Mahmoud Thabet
Dr
Mansoura University