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

Sponsor
Universiteit Antwerpen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03540056
Collaborator
(none)
600
1
118.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
Actual Study Start Date :
Oct 10, 2012
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Semen analysis in varicoele patients [After liquefaction (30-35 minutes after ejaculation)]

    Routine standard semen analysis as well as DNA fragmentation testing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 20 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antwerp University Hospital Edegem Antwerp Belgium 2650

Sponsors and Collaborators

  • Universiteit Antwerpen

Investigators

  • Study Director: Gunter De Win, MD PhD FEABU, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Donald Vaganée, Principal Investigator, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT03540056
Other Study ID Numbers:
  • B300201730926
First Posted:
May 30, 2018
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Donald Vaganée, Principal Investigator, Universiteit Antwerpen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2019