About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 18 to 50 years.
Couple infertility for at least 12 months.
Clinically palpable grade I to III varicocele confirmed by physical examination.
Abnormal semen parameters documented on at least two semen analyses performed 2 to 4 weeks apart according to World Health Organization laboratory standards.
Disqualifiers
Azoospermia or cryptozoospermia, defined as absence of sperm in the native ejaculate on at least two baseline semen analyses, including cases in which sperm are detected only after centrifugation.
Known clinically significant chromosomal or genetic abnormality that independently explains severe male infertility, when identified before enrollment.
Previous varicocelectomy of the index side.
Previous inguinal, scrotal, or retroperitoneal surgery that may alter spermatic cord anatomy.
Trial design
Parallel
Treatments tested in this trial
Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping
Procedure/SurgeryMicrosurgical 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 With Conventional Vein Ligation
Procedure/SurgeryStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Change in Sperm Concentration
Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.
Change in Total Sperm Count
Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.
Change in Progressive Sperm Motility
Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.
Sponsors and contacts
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