Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility

Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Male Infertility; Varicocele
• Intervention / Treatment: Procedure: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping; Procedure: Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed E Zahran, MD; Phone Number: +2 +20 10 07950278; Email: Ahmed.ebrahim@fmed.bu.edu.eg

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13511
      • Benha University Hospital
      • Contact: Ahmed E Zahran, MD; Phone Number: +2 0 10 07950278; Email: Ahmed.ebrahim@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Female partner evaluation completed or planned, with no untreated severe female factor that would make natural conception impossible.
• Willingness to comply with postoperative follow-up at 3, 6, and 12 months.
• Written informed consent.

Exclusion Criteria:

• 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.
• Subclinical varicocele only.
• Isolated scrotal pain with normal semen parameters.
• Hypogonadotropic hypogonadism requiring hormonal induction therapy.
• Testosterone therapy within the previous 6 months.
• Use of anti-estrogens, gonadotropins, or aromatase inhibitors within the previous 3 months.
• Active genitourinary infection.
• Testicular tumor or history of testicular cancer.
• Severe systemic disease contraindicating surgery or anesthesia.
• Inability to provide informed consent.
• Inability or unwillingness to complete follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microsurgical Varicocelectomy With Selective Extended Venous; 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; 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.
Active Comparator: Standard Microsurgical Subinguinal Varicocelectomy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 12 months after surgery
Operative time	Operative time will be measured from skin incision to completion of wound closure.	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.	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.	Up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy Outcome; Varicocele; Male Infertility; Semen Analysis; Microsurgical Varicocelectomy; Subinguinal Varicocelectomy; Venous Stripping; Scrotal Doppler Ultrasound; Varicocele Recurrence; Abnormal Semen Parameters
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male; Varicocele
• Other Study ID Numbers: RC 12-4-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No