Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

December 1, 2025 updated by: Ahmed Adel Ragab Mohamed, Assiut University

Impact of Reflux Flow Volume 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

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hatem Kamal Mohamed Abdelhafez, Medical doctorate
  • Phone Number: +20 01223971140
  • Email: Hatem76@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Male patients with bilateral clinical varicocele confirmed with scrotal color doppler Ultrasonography

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scrotal ultrasonographic parameter
Time Frame: Preoperative
Reflux volume(ml/min)
Preoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen parameter
Time Frame: Preoperative and 3 months postoperative
Sperm concentration (million/ml)
Preoperative and 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed Adel, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scrotal duplex in varicocele

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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