Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Expulsion rate of endometrial polyps
研究概览
简要总结
Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol
详细描述
The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered "gold standard" is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age
排除标准
- •Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management
研究组 & 干预措施
Misoprostol
干预措施: Misoprostol (Drug)
结局指标
主要结局
Expulsion rate of endometrial polyps
时间窗: 7 days after misoprostol has been applied
次要结局
- Pregnancy rate after expulsion(14-21 days after positive β-human Chorionic Gonadotropin (β-hCG))
- The pregnancy rate after expulsion in patients with primary sterility(14-21 days after positive β-hCG)
研究者
Henry Aristoteles Mate-Sánez
Principal Investigator
Mateo-Sánez, Henry A.