Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 主要终点
- The number of mature follicles
研究概览
简要总结
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse
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
- Double (Participant, Care Provider)
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
- •unexplained infertility, Primary or secondary.
- •Absence of galactorrhoea.
- •Normal serum prolactin.
- •Normal hysterosalpingography.
- •Normal spermogram.
排除标准
- •Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
- •Known hypersensitivity for cabergoline or clomiphene citrate.
- •Other factors of infertility as tubal factor, uterine factor or male factor.
研究组 & 干预措施
study group
will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)
干预措施: Clomiphene Citrate 50mg (Drug)
study group
will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)
干预措施: Cabergoline Oral Tablet (Drug)
control group
will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration
干预措施: Clomiphene Citrate 50mg (Drug)
control group
will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
The number of mature follicles
时间窗: 14 days
the follicles reach the size of 18 mm
次要结局
未报告次要终点
研究者
Ahmed Abdeltawab Mhanny
Principal investigator
Assiut University