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

Varicocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540056
• Other study ID #: B300201730926
• Status: Recruiting
• Start date: October 10, 2012
• Est. completion date: September 2022

Study information

• Verified date: October 2019
• Source: Universiteit Antwerpen
• Contact: Gunter De Win, MD PhD FEABU
• Phone: 3 821 55 86
• Email: gunter.dewin[@]uza.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 11 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Scrotal Disorder
• Varicocele

Intervention

Diagnostic Test:
• Ultrasound
We use ultrasound to measure the PRF and the testicular volumes.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Semen analysis in varicoele patients	Routine standard semen analysis as well as DNA fragmentation testing.	After liquefaction (30-35 minutes after ejaculation)