VaricoceleNCT03540056
Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
An observational study of Varicocele and Scrotal Disorder, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 11 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Varicocele, Scrotal Disorder
- What is being tested?
- Ultrasound
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2012to Sep 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 1. Boys aged 11-16 years without any evidence of a current or past pathology influencing testicular growth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Stefan De Wachter, MD PhD FEABU, 38215934 ext. +32, stefan.dewachter@uantwerpen.be
Thierry Vanderheyde
About this study
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.
- Conditions
- Varicocele, Scrotal Disorder
- Being tested
- Ultrasound
- Keywords
- varicocele, testicular growth
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
We use ultrasound to measure the PRF and the testicular volumes.
| Study group | Role | What they receive |
|---|---|---|
| Boys without varicocele | Boys thoroughly examined but without diagnose of varicocele Receives: Diagnostic Test: Ultrasound | |
| Boys with a varicocoele | Boys with a diagnosed varicocele of any stage possible. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (1)
Semen analysis in varicoele patients
Routine standard semen analysis as well as DNA fragmentation testing.
Measured: After liquefaction (30-35 minutes after ejaculation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start10 Oct 2012
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Vaganée, Universiteit Antwerpen
- Investigators
- Gunter De Win, MD PhD FEABU, Study director, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540056
- Sponsor's protocol ID
- B300201730926
- Status last verified
- Oct 2019
- First submitted
- 3 May 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
- ClinicalTrials.gov ID
- NCT03540056
- Acronym / sponsor ID
- B300201730926
- Conditions
- Varicocele, Scrotal Disorder
- Keywords
- varicocele, testicular growth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 10 Oct 2012 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boys without varicocele | – | Diagnostic Test: UltrasoundBoys thoroughly examined but without diagnose of varicocele |
| Boys with a varicocoele | – | Diagnostic Test: UltrasoundBoys with a diagnosed varicocele of any stage possible. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 1. Boys aged 11-16 years without any evidence of a current or past pathology influencing testicular growth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundWe use ultrasound to measure the PRF and the testicular volumes. | Diagnostic test | Boys with a varicocoele, Boys without varicocele |
Primary outcome
Change in testicular volumes in adolescents boys
Time frame: 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.
Chang in haemodynamic parameters in adolescent boys with a varicocele
Time frame: 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.
1 secondary outcome
Semen analysis in varicoele patients
Time frame: After liquefaction (30-35 minutes after ejaculation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunter De Win, MD PhD FEABU study director
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele and Scrotal Disorder, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gunter De Win, MD PhD FEABU (3 821 55 86 ext. +32, gunter.dewin@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in testicular volumes in adolescents boys (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.