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Not yet recruitingNCT06743932Updated Dec 20, 2024

A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy

An observational study in Varicocele, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Sex
All
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Study summary

Traditional surgical ligation of the spermatic cord veins is effective in reducing the size of the varicocele and improving fertility outcomes. However, this procedure can be associated with complications such as hydrocele formation and recurrence . Antegrade sclerotherapy offers a minimally invasive alternative, involving the injection of a sclerosing agent directly into the dilated veins to achieve occlusion and reduce reflux .

This study aims to optimize treatment outcomes for varicocele by combining the benefits of surgical ligation with the sclerosing effects of sclerotherapy .The primary goal is to evaluate the efficacy and safety of combining antegrade sclerotherapy and surgical ligation in the treatment of varicocele .

Read the detailed description

Varicocele (VC) is a vascular condition characterized by the abnormal development or blockage of veins in the scrotum, resulting in dilation, elongation, and twisting of the veins in the spermatic cord. Clinically, VC can cause scrotal pain, discomfort, and progressive testicular dysfunction. The prevalence of clinically diagnosed varicocele is approximately 8-16% in adolescents and 15% in adults. VC is a common and correctable cause of male infertility, responsible for around 44% of primary infertility cases . Other reports suggest that the prevalence in childhood and adolescence is similar to that in adulthood. A recent European study of 7,000 young men (median age: 19 years) reported a 15.7% prevalence of varicocele .

Severe and prolonged VC can lead to significant damage to the testes and accessory structures, causing 45-81% of secondary infertility cases. VC most commonly occurs on the left side (77-92% of cases) due to the anatomy of the left internal spermatic vein. Bilateral VC is observed in 10% of cases, while isolated right-sided VC is rare (1%). The diagnosis of VC is primarily based on physical examination, often supplemented by imaging . The American Society for Reproductive Medicine and the Society for Male Reproduction and Urology recommend treating VC favorably, even in the absence of severe symptoms, if it poses a risk for infertility or decreased semen quality. Treatment options for VC include general management (lifestyle modifications, physiotherapy), medication (for varicose symptoms, pain relief, and improvement in semen quality), and various surgical approaches (ligation of the internal spermatic vein via inguinal, retroperitoneal, or subinguinal routes) . Minimally invasive techniques, such as laparoscopy, surgical microscopy, and percutaneous embolization, have been developed to improve visualization and reduce surgical trauma.

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Conditions studied

  • Varicocele

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Keywords

  • Ligation
  • Sclerotherapy
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In context

Varicocele

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

This study's planned enrollment of 22 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.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

varicocele patients withClinically and Doppler confirmed grades II or III varicocele.

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

  • 1- Clinically and Doppler confirmed grades II or III varicocele. 2- All left, right or bilateral side varicocele. 3- Testicular pain or testicular atrophy. 4- Presence of at least one impaired semen parameter. 5- Age more than 18years

Exclusion criteria

Exclusion Criteria:

  • 1- Pre-existing hydrocele. 2- Concomitant hernia 3- Previous inguinal surgery
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Study design

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

Groups and cohorts

  • varicocel patients

    varicocele patients will be follow up after Ligation and Sclerotherapy

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What researchers measure

Primary outcomes

  1. varicocele grade

    Assess the change in varicocele grade from baseline to post-treatment using clinical examination and/or ultrasound

    Time frame: 30 day

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Abd Ellatif ME, Asker W, Abbas A, Negm A, Al-Katary M, El-Kaffas H, Moatamed A. Varicocelectomy to treat pain, and predictors of success: a prospective study. Curr Urol. 2012 May;6(1):33-6. doi: 10.1159/000338867. Epub 2012 Mar 18. PubMed 24917707 ↗
  • Su JS, Farber NJ, Vij SC. Pathophysiology and treatment options of varicocele: An overview. Andrologia. 2021 Feb;53(1):e13576. doi: 10.1111/and.13576. Epub 2020 Apr 9. PubMed 32271477 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2024
First posted
Dec 20, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
Jan 1, 2026
CompletionEst.
Mar 1, 2026
Last update
Dec 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06743932
Lead sponsor
Assiut University
Responsible party
Mohamed Mostafa Khedr (resident doctor at Assiut University hospital, Assiut University) — Principal investigator
First posted
Dec 20, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Dec 20, 2024

Study contacts

Mohamed Mostafa Khedr, resident doctor
Contact
hamadakhedr1988@yahoo.com
01098726393

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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