An interventional study of Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping and Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation in Varicocele and Male Infertility, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels under magnification. However, persistent or recurrent varicocele may still occur after surgery, possibly because of missed or persistent venous channels.
This randomized controlled trial will compare two surgical techniques in infertile men with clinically palpable varicocele and abnormal semen parameters. Participants will be randomly assigned to either microsurgical subinguinal varicocelectomy with selective extended venous stripping or standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division.
The main purpose of the study is to determine whether selective extended venous stripping reduces the rate of clinically and Doppler-confirmed persistent or recurrent varicocele at 12 months after surgery compared with the standard microsurgical technique. The study will also compare semen parameter improvement, pain improvement in participants with baseline pain, pregnancy outcomes, operative time, postoperative complications, and the need for additional treatment during 12 months of follow-up.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 160 is above the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping. Suitable clinically relevant dilated veins will be circumferentially dissected, mobilized, stripped over a defined segment, ligated, and divided when predefined safety criteria are met. Veins unsuitable for safe stripping will be treated by standard ligation and division, with documentation of the reason for non-stripping.
Procedure: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping
Participants randomized to this arm will undergo standard microsurgical subinguinal varicocelectomy with conventional ligation and division of identified veins requiring treatment under microscopic magnification. No venous stripping will be performed.
Procedure: Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation
Microsurgical subinguinal varicocelectomy performed under magnification with preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Favorable clinically relevant dilated veins will be dissected, mobilized, stripped over a defined segment, ligated, and divided. Veins not suitable for safe stripping will be treated by standard ligation and division.
Standard microsurgical subinguinal varicocelectomy performed under magnification. Identified veins requiring treatment will be isolated, ligated, and divided while preserving the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Venous stripping will not be performed.
Persistent or Recurrent Varicocele on the Operated Side
Persistent or recurrent varicocele will be defined as a palpable varicocele on standing physical examination confirmed by color Doppler ultrasound showing pampiniform plexus vein diameter of at least 3.0 millimeters with reflux lasting more than 2 seconds during Valsalva maneuver. For bilateral surgery, recurrence on either operated side will be counted as recurrence.
Time frame: 12 months after surgery
Change in Total Motile Sperm Count
Total motile sperm count will be calculated as semen volume multiplied by sperm concentration multiplied by total motility percentage. The mean of two baseline semen analyses will be used for baseline assessment.
Time frame: Baseline and 6 months after surgery
Change in Sperm Concentration
Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Count
Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Progressive Sperm Motility
Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Motility
Total sperm motility will be measured as the percentage of motile sperm on semen analysis.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Normal Sperm Morphology
Normal sperm morphology will be measured as the percentage of sperm with normal morphology on semen analysis.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain
Scrotal pain will be assessed using a 0 to 10 visual analog scale among participants who report baseline varicocele-related scrotal pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Number of Couples Achieving Spontaneous Pregnancy
Spontaneous pregnancy in the female partner will be recorded during follow-up and reported separately from assisted reproductive technology-related pregnancy.
Time frame: Up to 12 months after surgery
Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy
Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy.
Time frame: Up to 12 months after surgery
Operative time
Operative time will be measured from skin incision to completion of wound closure.
Time frame: Intraoperatively
Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele
Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded.
Time frame: 12 months after surgery
Number of Participants with Postoperative Complications
Postoperative complications will be recored after surgery. Complications will be graded according to the Clavien-Dindo classification of postoperative surgical complications, which classifies complications based on the treatment required, ranging from Grade I for minor deviations from normal recovery to Grade V for death.
Time frame: Up to 12 months after surgery
Plan to share: Yes — Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, operative variables, semen analysis parameters, pain scores, Doppler ultrasound findings, pregnancy outcomes, recurrence outcomes, and postoperative complications. No directly identifying participant information will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
Access criteria: Data will be shared with qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator and study investigators. Data will be provided only after approval of the request and, when required, completion of a data sharing agreement.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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