NCT03540056

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2012

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

9.8 years

First QC Date

May 3, 2018

Last Update Submit

October 13, 2019

Conditions

VaricoceleScrotal Disorder

Keywords

varicoceletesticular growth

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Semen analysis in varicoele patients

    After liquefaction (30-35 minutes after ejaculation)

Study Arms (2)

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

UltrasoundDIAGNOSTIC_TEST

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

Boys with a varicocoeleBoys without varicocele

Eligibility Criteria

Age11 Years - 20 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Varicocele

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gunter De Win, MD PhD FEABU

    University Hospital, Antwerp

    STUDY DIRECTOR

Central Study Contacts

Gunter De Win, MD PhD FEABU

CONTACT

3 821 55 86gunter.dewin@uza.be

Donald Vaganée, Dr.

CONTACT

3 821 30 47donald.vaganee@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 30, 2018

Study Start

October 10, 2012

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)