Clinical trial NCT03540056: Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
Official title: Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicocele
Scrotal Disorder
Keywords: varicocele
testicular growth
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 600
Sex: MALE
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in testicular volumes in adolescents boys
timeFrame: 3 years
measure: Chang in haemodynamic parameters in adolescent boys with a varicocele
timeFrame: 3 years
Secondary outcomes:
measure: Semen analysis in varicoele patients
timeFrame: After liquefaction (30-35 minutes after ejaculation)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Gunter De Win, MD PhD FEABU
role: STUDY_DIRECTOR
References: