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NCT Number: NCT07263009

Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

Evaluation of the impact of reflux flow volume and other ultrasonographic diagnostic parameters of varicocele on semen parameters before and 3 months varicocelectomy

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Observational

About this study

Varicocele is an abnormal dilatation and tortuosity of the pampiniform plexus of veins draining the testicles. It affects almost 15% of men in the general population, but its prevalence rises significantly reaching 35-40% among men with primary infertility and up to 80% of men with secondary infertility. Varicocele is known to have a deleterious effect on spermatogenesis through multiple mechanisms, resulting in a progressive decline in semen parameters. However, the precise pathophysiological impact of varicocele on male infertility is still unclear. Although clinical examination is considered the standard diagnostic method , a considerable number of varicocele can be detected via ultrasound. Color Doppler Ultrasonography (CDUS) is widely used as a non-invasive diagnostic tool for varicocele, mainly through detection of venous reflux which is a key diagnostic criterion. As the current CDUS-based grading systems rely on subjective and individual parameters which may not fully represent the harmful effect caused by the condition, there is a critical need for a more integrated and quantifiable parameter that can better predict the severity of testicular dysfunction and guide its treatment. Reflux flow volume is a quantitative parameter measured via the CDUS, referring to the rate of retrograde blood flow passing through the dilated veins during reflux episodes. This parameter integrates reflux duration, velocity and vein diameter. Thus, it can provide a more comprehensive assessment of reflux severity than any of the individual components alone. Consequently, reflux flow volume can serve as a reliable marker for testicular function. By investigating its relation to other ultrasonographic parameters, testicular volume and their impact on semen parameters, testosterone and follicle stimulating hormone (FSH) levels, it has the potential to transform diagnostic strategies and predict the impact of varicocelectomy on spermatogenesis and hormonal changes. Therefore, it can stratify patients for the therapeutic approach and provide a better prognostic tool for varicocele management

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with bilateral clinical varicocele confirmed by Scrotal Color Doppler Ultrasonography

Exclusion criteria

  • Unilateral varicocele.
  • Recurrent varicocele.
  • History of undescended testis, orchitis, testicular trauma, torsion or scrotal surgery.
  • Inguinal hernia, hydrocele or scrotal mass.
  • Prior chemotherapy, radiotherapy or any other gonadotoxic agents.
  • Uncontrolled systemic illness.
  • Chromosomal or genetic anomalies.
  • Azoospermia and severe oligozoospermia (< 5 million/ml)

Treatment and study plan

Primary outcomes

  1. Scrotal ultrasonographic parameter

    Time frame: Preoperative

    Reflux volume(ml/min)

Secondary outcomes

  1. Semen parameter

    Time frame: Preoperative and 3 months postoperative

    Sperm concentration (million/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Adel Ragab Mohamed, Bachelor

CONTACT

[email protected]

+20 01002068386

Hatem Kamal Mohamed Abdelhafez, Medical doctorate

CONTACT

[email protected]

+20 01223971140

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Reflux Flow Volume on Semen Parameters Pre and Post Varicocelectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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