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临床试验/NCT03341897
NCT03341897Unknown不适用

Endovasculer Treatement of Male Pelvic Venous Insufficiency

Assiut University0 个研究点目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
semen analysis criteria

研究概览

简要总结

A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of the general population but is detected in as many as 40% of men undergoing an infertility workup. Depending on the method used for diagnosis, varicoceles are reported as bilateral in 17% to 77% of men. Traditionally, the diagnosis was made through clinical examination; however,as with other venous reflux disorders, ultrasound has become the mainstay of diagnosis. The traditional indications for treatment include infertility in patients with appropriate semen abnormalities, chronic groin pain, testicular atrophy in adolescent varicoceles, and recurrent varicocele after previous repair. Other indications more recently described with variable strength of evidence include low serum testosterone (with or without erectile dysfunction), benign prostatic hypertrophy,enhancement of assisted fertility techniques, and recurrent first trimester pregnancy loss.Infertility affects 10% to 15% of men of reproductive age. In approximately 50%, a cause is not found. The proof that varicocele repair improves fertility remains elusive; however, there is general acceptance that treatment does improve abnormalities of semen production.The traditional measures to assess semen production are sperm motility,morphology, and total sperm count. However, sperm counts greatly vary from day to day in any individual patient, and these measures correlate poorly with infertility outcomes.

The investigators do this study to evaluate the effectiveness of endovascular therapy using coils and other sclerosing agents and compare their results with other traditonal surgical methods in treatement of varicocele.

详细描述

All included patients will undergo the following:

  • History & examination
  • Semen analysis preintervention.
  • Scrotal duplex scan of testicular vessels and testicular size .

Technique:

  • All interventions will be performed in the endovascular OR with set on C-ARM.
  • Patient's position and comfort are issues that are important initially.

STEPS FOR SPERMATIC VENOGRAPHY AND VARICOCELE EMBOLIZATION

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 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age between 18 to 40 years.
  • Grade three reflux by duplex ultrasound..
  • Recurrent varicocele after surgical treatement.

排除标准

  • Any contraindication for endovascular therapy regarding radiation or dye or sclerosing agents.

结局指标

主要结局

semen analysis criteria

时间窗: 3 month

sperm motility

semen analyis criteria

时间窗: 3 month

sperm number in milion/ml

次要结局

未报告次要终点

研究者

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

Ahmed Mohamed Abbas

principal investigator

Assiut University

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