Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy rate per cycle
研究概览
简要总结
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
详细描述
100 women with infertility classified into 2 groups.
Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day.
Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.
Folliculometry was assessed by:
- Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Infertile women whether it's primary or secondary infertility
- •Woman's age: (18-35 years old)
- •Menstrual cycle from (24-35 days)
- •Normal semen analysis
排除标准
- •Age more than 35 years old
- •Ovarian cysts
- •Abnormal hormonal profile (e.g hyperprolactinaemia)
- •Significant cardiovascular disease
- •Serious liver disease or renal failure
- •Poorly controlled diabetes mellitus
研究组 & 干预措施
sildenafil citrate
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day
干预措施: Clomiphene citrate (Drug)
sildenafil citrate
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day
干预措施: sildenafil citrate (Drug)
placebo group
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day
干预措施: Clomiphene citrate (Drug)
placebo group
50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day
干预措施: Placebo (Drug)
结局指标
主要结局
Pregnancy rate per cycle
时间窗: 14 days after HCG triggering of ovulation
Serum pregnancy test
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University