VaricoceleNCT07263009
Reflux Flow Volume Impact on Semen Parameters Pre and Post Varicocelectomy
An observational study of Varicocele, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Varicocele
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2026
- 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 20 to 50 years
- Men only
- Adult
Study population: Male patients with bilateral clinical varicocele confirmed with scrotal color doppler Ultrasonography
Who may be able to join
- Patients with bilateral clinical varicocele confirmed by Scrotal Color Doppler Ultrasonography
Who cannot join
- 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)
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: 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
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
- Conditions
- Varicocele
- Keywords
- Scrotal duplex, Varicocele, Semen parameters, Reflux flow volume
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scrotal ultrasonographic parameter
Reflux volume(ml/min)
Measured: Preoperative
Secondary outcomes (1)
Semen parameter
Sperm concentration (million/ml)
Measured: Preoperative and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Ragab Mohamed, Assiut University
- Investigators
- Ahmed Adel, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263009
- Sponsor's protocol ID
- Scrotal duplex in varicocele
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
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 32271466Bagheri 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 29695731Kocakoc 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reflux Flow Volume on Semen Parameters Pre and Post Varicocelectomy
- ClinicalTrials.gov ID
- NCT07263009
- Acronym / sponsor ID
- Scrotal duplex in varicocele
- Conditions
- Varicocele
- Keywords
- Scrotal duplex, Varicocele, Semen parameters, Reflux flow volume
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bilateral clinical varicocele confirmed with scrotal color Doppler Ultrasonography | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Male patients with bilateral clinical varicocele confirmed with scrotal color doppler Ultrasonography
Key inclusion criteria (1 listed)
- Patients with bilateral clinical varicocele confirmed by Scrotal Color Doppler Ultrasonography
Key exclusion criteria (8 listed)
- 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.
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
Scrotal ultrasonographic parameter
Time frame: Preoperative
Reflux volume(ml/min)
1 secondary outcome
Semen parameter
Time frame: Preoperative and 3 months postoperative
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 4 Dec 2025.
- Background: PubMed 32271466Senturk 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.
- Background: PubMed 29695731Bagheri 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.
- Background: PubMed 12927671Kocakoc 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.
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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.
Ahmed Adel principal investigator
Assiut University
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 1 inclusion and 8 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 4 Dec 2025. 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 Ahmed Adel Ragab Mohamed, Bachelor (+20 01002068386, Ahmed.17289538@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scrotal ultrasonographic parameter (time frame: Preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07263009, which also lists 3 linked publications.
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 4 Dec 2025.