VaricoceleNCT07836413
Internal Spermatic Vein Histopathology in Patients Undergoing Varicocelectomy
An observational study of Varicocele, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Varicocele
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Male patients with clinically palpable varicocele.
- Scheduled for varicocelectomy.
- Preoperative scrotal duplex ultrasonography available.
- Preoperative semen analysis available.
- Written informed consent for participation.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Internal Spermatic Vein Histopathology and Its Relationships With Clinical, Laboratory, and Duplex Ultrasound Parameters in Patients Undergoing Varicocelectomy: A Prospective Cohort Study
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.
Read the detailed description
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.
- Conditions
- Varicocele
- Keywords
- Vein Histopathology, Pampiniform Plexus, Varicocelectomy, Scrotal Duplex Ultrasound, Semen Analysis
- Medical subject headings
- Varicocele
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively and at the time of varicocelectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Maged Fathy Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836413
- Sponsor's protocol ID
- AUS-VARICOCELE-2026-01
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Spermatic Vein Histopathology and Its Relationships With Clinical, Laboratory, and Duplex Ultrasound Parameters in Patients Undergoing Varicocelectomy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07836413
- Acronym / sponsor ID
- AUS-VARICOCELE-2026-01
- Conditions
- Varicocele
- Keywords
- Vein Histopathology, Pampiniform Plexus, Varicocelectomy, Scrotal Duplex Ultrasound, Semen Analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Male patients with clinically palpable varicocele.
- Scheduled for varicocelectomy.
- Preoperative scrotal duplex ultrasonography available.
- Preoperative semen analysis available.
- Written informed consent for participation.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Maged Mahmoud, MBBCH (+201120568961, Khaled.18313359@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Internal Spermatic Vein Histopathological Parameters With Clinical, Duplex Ultrasound, and Semen Parameters (time frame: Preoperatively and at the time of varicocelectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.