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

• Conditions: Scrotal Disorder; Varicocele
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03540056
• Lead Sponsor: Universiteit Antwerpen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-10
• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-13
• Last Update Posted: 2019-10-15
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

1. 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)
2. Boys with evidence of disorders influencing testicular growth (e.g. growth disorders)
3. Boys with missing or incomplete data on Tanner stages for genital development
4. Boys with a psychiatric disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boys without varicocele	Ultrasound	Boys thoroughly examined but without diagnose of varicocele
Boys with a varicocoele	Ultrasound	Boys with a diagnosed varicocele of any stage possible.

Primary Outcome Measures

Name	Time	Method
Change in testicular volumes in adolescents boys	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	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.

Secondary Outcome Measures

Name	Time	Method
Semen analysis in varicoele patients	After liquefaction (30-35 minutes after ejaculation)	Routine standard semen analysis as well as DNA fragmentation testing.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium