ClinicalTrials.gg
Not yet recruitingNCT07263009Updated Dec 4, 2025

Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

An observational study in Varicocele, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 50 Years
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

  • Varicocele

Browse trials for

Keywords

  • Scrotal duplex
  • Varicocele
  • Semen parameters
  • Reflux flow volume
03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's planned enrollment of 100 is below the median of 119 across 17 observational studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with bilateral clinical varicocele confirmed by Scrotal Color Doppler Ultrasonography

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography
06

What researchers measure

Primary outcomes

  1. Scrotal ultrasonographic parameter

    Reflux volume(ml/min)

    Time frame: Preoperative

Secondary outcomes

  1. Semen parameter

    Sperm concentration (million/ml)

    Time frame: Preoperative and 3 months postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Senturk AB, Cakiroglu B, Yaytokgil M, Aydin C, Sungur M, Akkoc A. Effect of venous reflux time on testosterone and semen parameters of infertile males after microscopic varicocelectomy. Andrologia. 2020 Jul;52(6):e13583. doi: 10.1111/and.13583. Epub 2020 Apr 9. PubMed 32271466 ↗
  • Bagheri SM, Khajehasani F, Iraji H, Fatemi I. A Novel Method for Investigating the Role of Reflux Pattern in Color Doppler Ultrasound for Grading of Varicocele. Sci Rep. 2018 Apr 25;8(1):6517. doi: 10.1038/s41598-018-24890-2. PubMed 29695731 ↗
  • Kocakoc E, Serhatlioglu S, Kiris A, Bozgeyik Z, Ozdemir H, Bodakci MN. Color Doppler sonographic evaluation of inter-relations between diameter, reflux and flow volume of testicular veins in varicocele. Eur J Radiol. 2003 Sep;47(3):251-6. doi: 10.1016/s0720-048x(02)00182-1. PubMed 12927671 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07263009
Lead sponsor
Assiut University
Responsible party
Ahmed Adel Ragab Mohamed (Resident doctor, Assiut University) — Principal investigator
First posted
Dec 4, 2025
Start date
Dec 2025 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 4, 2025

Study contacts

Ahmed Adel Ragab Mohamed, Bachelor
Contact
Ahmed.17289538@med.aun.edu.eg
+20 01002068386
Hatem Kamal Mohamed Abdelhafez, Medical doctorate
Contact
Hatem76@gmail.com
+20 01223971140
Ahmed Adel
principal investigator · Assiut University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion