Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
this study is to investigate the success rate of proximal tubal occlusion with coil devices in women with hydrosalinx and to observe there pregnancy rate with IVF-ET.
详细描述
In this study, investigators will recruit 80 females with unilateral or bilateral hydrosalpinx as confirmed by HSG. Tubal ligation may be a safe and effective method in the treatment of hydrosalpinx. But in this study, investigators will use fiber platinum coils to occlude the tubes. After the treatment, IVF-ET will be applied,and then the patients' pregnancy rate will be assessed in the following-up.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have unilateral or bilateral hydrosalpinxs as evidenced by HSG.
- •laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions.
- •Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion.
- •Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study.
- •Have read, understood and signed an informed consent form .
排除标准
- •Active or recent upper or lower pelvic infection
- •Known hypersensitivity to nickel as confirmed by skin test
- •Known allergy to contrast media Pregnancy or suspected pregnancy
- •Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
- •Poor general or gynecologic health
- •Inability or refusal to provide informed consent
结局指标
主要结局
Pregnancy rate
时间窗: 2 months after IVF-ET
Patients will be followed up with the pregnancy outcomes after the tubal occlusion
次要结局
未报告次要终点
研究者
Feng Lin
Associate Chief Physician
First Affiliated Hospital of Wenzhou Medical University