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Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

A

Assiut University

Status

Not yet enrolling

Conditions

Varicocele

Study type

Observational

Funder types

Other

Identifiers

NCT07263009
Scrotal duplex in varicocele

Details and patient eligibility

About

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

Full description

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

Enrollment

100 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography

Trial contacts and locations

0

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Central trial contact

Ahmed Adel Ragab Mohamed, Bachelor; Hatem Kamal Mohamed Abdelhafez, Medical doctorate

Data sourced from clinicaltrials.gov

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