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临床试验/NCT05537805
NCT05537805Unknown不适用

Ultrasound Guided Transcervical Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography in the Treatment of Proximal Tubal Obstruction

Assaf-Harofeh Medical Center0 个研究点目标入组 30 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Number of participants with proximal tubal obstruction who referred for tubal catheterization in order to achieve fallopian tube recanalization (patency).

研究概览

简要总结

Investigate a novel ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction.

详细描述

Tubal catheterization is usually reserved for infertility treatment in selected cases of proximal tubal occlusion. As the incidence of this condition is limited to approximately 10-20% of women with mechanical infertility, the hitherto published data concerning the best therapeutic approach for these patients is scarce.

Hysterolaparoscopy with dye instillation is considered the gold standard for comprehensive evaluation of the female reproductive organs. Moreover, while the gold standard for evaluation of the uterine cavity is diagnostic hysteroscopy and hydrosonography, tubal patency may be validated by either hystrosalpingography, or ultrasonic evaluation using Echovist-200. However, interpretation of the passage of contrast medium into the proximal portion of the tube remains somewhat uncertain.

Since hysterolaparoscopy with dye instillation, is an expensive and an invasive procedure, with potentially life-threatening risks, the search for a safer and less invasive techniques is still ongoing. In 2012, Hysterosalpingo-Foam Sonography was introduced as a new technique for assessing fallopian tube patency. During the exam, the passage of a hyper-echogenic foam composed of a mixture of gel and purified water can be visualized as it progresses from the uterine cavity through the fallopian tubes into the peritoneal cavity. Hysterosalpingo-foam sonography is a promising alternative for laparoscopy and hysterosalpingography with regard to accuracy and effectiveness and has been suggested as a first step test of tubal assessment since it is relatively safe, non (embryo-) toxic and non-invasive.

In the present report the investigators aim to perform an ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonographyin the treatment of proximal tubal obstruction. This "one stop - shop" procedure combines uterine cavity investigation and assessment of tubal patency, with the concomitant advantage of therapeutic tubal re-canalization.

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

入选标准

  • uni or/and bilateral proximal tubal occlusion.

排除标准

  • ongoing pregnancy
  • positive Human Chorionic Gonadotropin test
  • active pelvic inflammatory disease
  • vaginal bleeding
  • presence of distal tubal occlusion

结局指标

主要结局

Number of participants with proximal tubal obstruction who referred for tubal catheterization in order to achieve fallopian tube recanalization (patency).

时间窗: 18 month

Tubal patency after tubal catheterization procedure demonstrated by hysterosalpingo-foam sonography.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yaakov Melcer

Prof

Assaf-Harofeh Medical Center

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