Prospective Randomized Study of Ovulation Induction Using Either Tamoxifen or Clomiphene Citrate for Women Who Had Thin Endometrium During Previous Treatment With Clomiphene Citrate
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
About 10-15% of all couples attempting to conceive will not become pregnant within one year. Among those, the majority will have ovulatory dysfunction, mild male infertility or unexplained infertility. The traditional first line therapy for those couples is ovulation induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects of this agent will, some patients will have a thin endometrium as measured by sonography at the time of ovulation. This phenomenon may be associated with a lower chance to conceive. Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown to be equally effective to clomiphene in ovulation induction. Preliminary observations showed that tamoxifen does not cause a negative effect on the endometrium as compared with clomiphene, and may increase the chance to conceive in those patients who have a thin endometrium under clomiphene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Primary or secondary infertility due to:
- •Ovulatory dysfunction
- •Mild male infertility
- •Unexplained infertility
- •Endometrium < 6 mm at time of hCG during previous treatment with clomiphene citrate
- •Age 18-35
排除标准
- •Serious adverse effects under clomiphene citrate or known sensitivity to either tamoxifen or clomiphene citrate
结局指标
主要结局
Pregnancy rate
delivery rate
次要结局
- endometrium thickness
- percentage of ovulation
- number of follicles
