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

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.

Study Overview

• Status: Unknown
• Conditions: Varicocele; Scrotal Disorder
• Intervention / Treatment: Diagnostic test: Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Gunter De Win, MD PhD FEABU; Phone Number: +32 3 821 55 86; Email: gunter.dewin@uza.be
• Study Contact Backup: Name: Donald Vaganée, Dr.; Phone Number: +32 3 821 30 47; Email: donald.vaganee@gmail.com

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Stefan De Wachter, MD PhD FEABU; Phone Number: +32 38215934; Email: stefan.dewachter@uantwerpen.be
      • Sub-Investigator: Thierry Vanderheyde
      • Sub-Investigator: Valérie van Dam
      • Sub-Investigator: Cynthia Leysen
      • Sub-Investigator: Ward Bauwens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adolescent boys with or without a varicocele being between the age 11 and 16 years old when enlisting in the study. Recruitment took place at the Antwerp University Hospital and through medical checkups in secondary schools in Antwerp and West-Flanders.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Boys without varicocele; Boys thoroughly examined but without diagnose of varicocele	Diagnostic test: Ultrasound; We use ultrasound to measure the PRF and the testicular volumes.
Boys with a varicocoele; Boys with a diagnosed varicocele of any stage possible.	Diagnostic test: Ultrasound; We use ultrasound to measure the PRF and the testicular volumes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in testicular volumes in adolescents boys	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.	3 years
Chang in haemodynamic parameters in adolescent boys with a varicocele	Scrotal doppler ultrasound is performed and the peak retrograde flow is determined. Multiple measurements are performed over a time period of 3 years.	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Study Director: Gunter De Win, MD PhD FEABU, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2012
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: varicocele; testicular growth
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicocele
• Other Study ID Numbers: B300201730926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No