Internal Spermatic Vein Histopathology in Patients Undergoing Varicocelectomy

Varicocele is an enlargement of the veins around the testicle and may affect male fertility. This prospective observational study will include men with varicocele who are undergoing varicocelectomy. The study aims to examine whether changes in the structure of the internal spermatic veins are related to clinical findings, semen analysis results, and scrotal duplex ultrasound findings.

During varicocelectomy, vein tissue that is removed as part of the surgical procedure will be collected and examined under a microscope. Digital image analysis will also be used to measure different features of the vein wall, including its thickness and the amounts of smooth muscle and collagen.

In participants undergoing surgery for varicocele on both sides, the findings from the left and right spermatic veins will also be compared. The study does not assign participants to varicocelectomy; the decision to perform surgery is based on their clinical care.

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Key information

Conditions

Varicocele Cardiovascular Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases Vascular Diseases

Sex eligibility

Male

Study type

Observational

About this study

This prospective cohort study will include male patients with clinically palpable varicocele who are scheduled to undergo varicocelectomy at Assiut University Hospitals.

Preoperative assessment will include clinical evaluation, semen analysis, and scrotal duplex ultrasonography. Clinical assessment will include age, laterality, and clinical varicocele grade. Semen parameters will include semen volume, sperm concentration, total sperm count, progressive motility, non-progressive motility, and sperm morphology. Duplex ultrasound assessment will include right and left testicular volume, maximum spermatic vein diameter, presence of venous reflux, and reflux duration.

Internal spermatic vein specimens excised during varicocelectomy will undergo histopathological and digital morphometric assessment. Specimens will be routinely processed and stained with hematoxylin and eosin and Masson's trichrome. Digital morphometric analysis will be performed using QuPath to quantitatively assess total venous wall area, wall thickness, wall-thickness-to-lumen-diameter ratio, smooth-muscle area, collagen area, and muscle-to-collagen ratio.

The relationships between these histopathological measurements and clinical characteristics, duplex ultrasound findings, and semen parameters will be evaluated. In participants with bilateral varicocele undergoing bilateral varicocelectomy, left and right spermatic vein specimens will be assessed separately to allow paired comparison of histopathological and quantitative morphometric findings and their relationships with corresponding side-specific clinical and duplex ultrasound findings.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male patients with clinically palpable varicocele.
Scheduled for varicocelectomy.
Preoperative scrotal duplex ultrasonography available.
Preoperative semen analysis available.
Written informed consent for participation.

Exclusion criteria

Previous varicocelectomy on the affected side.
Previous major scrotal or testicular surgery affecting the study side.
Obstructive causes of azoospermia, when applicable to the semen analysis component.
Hormonal treatment that may significantly alter semen parameters.
Incomplete clinical, duplex ultrasound, or semen analysis data.
Declines participation.

Treatment and study plan

Primary outcomes

Correlation of Internal Spermatic Vein Histopathological Parameters With Clinical, Duplex Ultrasound, and Semen Parameters

Time frame: Preoperatively and at the time of varicocelectomy

Internal spermatic vein histopathological parameters will be quantified using QuPath digital morphometric analysis and correlated with prespecified clinical, duplex ultrasound, and semen parameters using Pearson or Spearman correlation, as appropriate. Histopathological parameters include total wall area, wall thickness, wall-thickness-to-lumen-diameter ratio, smooth muscle area (% of wall and % of media), collagen area (% of wall and % of adventitia), and muscle-to-collagen ratio.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Internal Spermatic Vein Histopathology and Its Relationships With Clinical, Laboratory, and Duplex Ultrasound Parameters in Patients Undergoing Varicocelectomy: A Prospective Cohort Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Sep 23, 2026
Registry last updated: Sep 23, 2026

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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