Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy

NCT ID: NCT07263009

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Varicocele

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Adel Ragab Mohamed

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Adel

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Ahmed Adel Ragab Mohamed, Bachelor

Role: CONTACT

+20 01002068386

Hatem Kamal Mohamed Abdelhafez, Medical doctorate

Role: CONTACT

+20 01223971140

References

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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.

Reference Type BACKGROUND
PMID: 32271466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29695731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12927671 (View on PubMed)

Other Identifiers

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Scrotal duplex in varicocele

Identifier Type: -

Identifier Source: org_study_id

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