ClinicalTrials.gg
Status unknownNCT03540056Updated Oct 15, 2019

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

An observational study in Varicocele and Scrotal Disorder, sponsored by Universiteit Antwerpen. Status unknown at 1 site in Belgium. Open to male participants aged 11 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Universiteit Antwerpen · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
600
Ages
11 Years to 20 Years
Sex
Male
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Study 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.

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Conditions studied

  • Varicocele
  • Scrotal Disorder

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Keywords

  • varicocele
  • testicular growth
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In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's planned enrollment of 600 is above the median of 119 across 17 observational studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Universiteit Antwerpen is the lead sponsor of 135 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 20 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Target follow-up
7 Years
Patient registry
Yes

Groups and cohorts

  • Boys without varicocele

    Boys thoroughly examined but without diagnose of varicocele

    Diagnostic Test: Ultrasound

  • Boys with a varicocoele

    Boys with a diagnosed varicocele of any stage possible.

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    We use ultrasound to measure the PRF and the testicular volumes.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

Secondary outcomes

  1. Semen analysis in varicoele patients

    Routine standard semen analysis as well as DNA fragmentation testing.

    Time frame: After liquefaction (30-35 minutes after ejaculation)

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Study locations

1 of 1 sites recruiting
  • Antwerp University Hospital
    Edegem, Antwerp 2650, Belgium
    Recruiting
    • Stefan De Wachter, MD PhD FEABU · Contactstefan.dewachter@uantwerpen.be · 38215934
    • Thierry Vanderheyde · Sub investigator
    • Valérie van Dam · Sub investigator
    • Cynthia Leysen · Sub investigator
    • Ward Bauwens · Sub investigator
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03540056
Responsible party
Donald Vaganée (Principal Investigator, Universiteit Antwerpen) — Principal investigator
First posted
May 30, 2018
Start date
Oct 10, 2012
Primary completion
Aug 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Oct 15, 2019

Study contacts

Gunter De Win, MD PhD FEABU
Contact
gunter.dewin@uza.be
3 821 55 86 ext. +32
Donald Vaganée, Dr.
Contact
donald.vaganee@gmail.com
3 821 30 47 ext. +32
Gunter De Win, MD PhD FEABU
study director · University Hospital, Antwerp

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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