NCT02663830已完成2 期
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 21-35 years.
- •Anovulatory cycles due to polycystic ovaries syndrome.
- •Non-smokers.
- •Free of major medical illness
排除标准
- •Women with myoma or adenomyosis
- •Women with congenital uterine anomaly.
- •Chronic use of any medications including non-steroidal anti-inflammatory drugs.
- •Associated cases of infertility other than PCOs (male factor, tubal factor,....).
- •Asherman syndrome.
- •Cases with endometrial hyperplasia.
- •Cases with endometrial polyp
研究组 & 干预措施
clomiphene only
Active Comparator
105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).
干预措施: clomiphene only (Drug)
(Sildenafil & clomiphene citrate group)
Experimental
105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
干预措施: Sildenafil & clomiphene citrate (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6 weeks
次要结局
- miscarriage rate(13 weeks)
- endometrial thickness(2 weeks)
- Side Effects of Vasodilators(4 weeks)
- ectopic pregnancy rate(8 weeks)
研究者
Ahmed Abdel Shafy El Shahawy
Lecturer
Ain Shams University
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