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

NCT07605351 | Not Yet Recruiting

• 1 other identifier: RC 12-4-2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicocele; Male Infertility

Keywords

Varicocele; Male Infertility; Microsurgical Varicocelectomy; Subinguinal Varicocelectomy; Venous Stripping; Semen Analysis; Scrotal Doppler Ultrasound; Varicocele Recurrence; Abnormal Semen Parameters; Pregnancy Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Total Motile Sperm Count

  Baseline and 6 months after surgery

• Change in Sperm Concentration

  Baseline, 3 months, 6 months, and 12 months after surgery

• Change in Total Sperm Count

  Baseline, 3 months, 6 months, and 12 months after surgery

• Change in Progressive Sperm Motility

  Baseline, 3 months, 6 months, and 12 months after surgery

• Change in Total Sperm Motility

  Baseline, 3 months, 6 months, and 12 months after surgery

Study Arms (2)

Microsurgical Varicocelectomy With Selective Extended Venous

EXPERIMENTAL

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

Standard Microsurgical Subinguinal Varicocelectomy

ACTIVE COMPARATOR

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

Interventions

Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping PROCEDURE

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.

Microsurgical Varicocelectomy With Selective Extended Venous

Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation PROCEDURE

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.

Standard Microsurgical Subinguinal Varicocelectomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Varicocele; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Infertility

Central Study Contacts

Ahmed E Zahran, MD

CONTACT

+20 10 07950278; Ahmed.ebrahim@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Operating surgeons cannot be blinded because of the nature of the surgical procedures. Participants, semen laboratory personnel, Doppler ultrasound assessors, clinicians assessing postoperative recurrence, and the data analyst will remain blinded to treatment allocation whenever feasible until database lock. Operative details that may reveal allocation will not be disclosed to outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Participants will be randomly assigned in a one-to-one ratio to one of two parallel surgical treatment arms. One arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping, and the other arm will undergo standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division. Participants will remain in their assigned treatment arm throughout 12 months of follow-up.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

EG (1)