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临床试验/NCT03540056
NCT03540056Unknown不适用

Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年10月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Change in testicular volumes in adolescents boys

研究概览

简要总结

Prospective observational study.

A varicocele is defined as a dilatation of the veins in the plexus pampiniformis in the testicles. Varicoceles are a diagnostic dilemma and a therapeutic challenge. Most of the boys with a varicocele don't show any symptoms, but approximately 15-20% experience some sort of infertility later during their life. There still isn't any consensus on when treating the patient is the right choice. Reliable scientific research about parameters able to predict the later stages of the boy with a varicocele is therefore needed. The purpose of this study is to how testicular growth could predict the outcome of boys with a varicocele.

During this study, testicular growth in boys with and without a left-sided varicocele will be examined in different schools using ultrasound to measure the testicular volumes, the PRF and the TAI to be able to collect sufficient data with the purpose to be able to predict whether testicular growth is a significant predictor on the progression of a varicocele.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 20 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Boys aged 11-16 years without any evidence of a current or past pathology influencing testicular growth

排除标准

  • Boys with a current or past inguinoscrotal pathology (varicocele, testicular microlithiasis, cryptorchidism, retractile testis, orchidectomy, testicular torsion, orchitis or epididymitis, hypospadias, inguinal hernia, oeprated varicocele, hydrocele and epididymal cysts)
  • Boys with evidence of disorders influencing testicular growth (e.g. growth disorders)
  • Boys with missing or incomplete data on Tanner stages for genital development
  • Boys with a psychiatric disorder

结局指标

主要结局

Change in testicular volumes in adolescents boys

时间窗: 3 years

Scrotal ultrasound is performed to assess testicular dimensions after which testicular volume is calculated. Multiple measurements are performed over a time period of 3 years.

Chang in haemodynamic parameters in adolescent boys with a varicocele

时间窗: 3 years

Scrotal doppler ultrasound is performed and the peak retrograde flow is determined. Multiple measurements are performed over a time period of 3 years.

次要结局

  • Semen analysis in varicoele patients(After liquefaction (30-35 minutes after ejaculation))

研究者

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

Donald Vaganée

Principal Investigator

Universiteit Antwerpen

研究点 (1)

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