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

NCT ID: NCT03540056

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-10

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Varicocele Scrotal Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Boys without varicocele

Boys thoroughly examined but without diagnose of varicocele

Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Boys with a varicocoele

Boys with a diagnosed varicocele of any stage possible.

Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

11 Years

Maximum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Donald Vaganée

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gunter De Win, MD PhD FEABU

Role: STUDY_DIRECTOR

University Hospital, Antwerp

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gunter De Win, MD PhD FEABU

Role: CONTACT

3 821 55 86 ext. +32

Donald Vaganée, Dr.

Role: CONTACT

3 821 30 47 ext. +32

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stefan De Wachter, MD PhD FEABU

Role: primary

38215934 ext. +32

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B300201730926

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.