An observational study in Varicocele, sponsored by Assiut University. Not yet recruiting. Open to male participants. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assiut University · Observational
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.
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 70 is below the median of 119 across 17 observational studies indexed under Varicocele.
Browse Varicocele studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Male patients with clinically palpable varicocele who are scheduled to undergo varicocelectomy at Assiut University Hospitals. Eligible participants will undergo preoperative clinical assessment, semen analysis, and scrotal duplex ultrasonography. Internal spermatic vein specimens excised during varicocelectomy will undergo histopathological and quantitative digital morphometric assessment.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Correlation of Internal Spermatic Vein Histopathological Parameters With Clinical, Duplex Ultrasound, and Semen Parameters
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.
Time frame: Preoperatively and at the time of varicocelectomy
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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