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NCT Number: NCT07605351

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location contact

Ahmed E Zahran, MD

CONTACT

[email protected]

0 10 07950278 ext. +2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Persistent or Recurrent Varicocele on the Operated Side

    Time frame: 12 months after surgery

    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

  1. Change in Total Motile Sperm Count

    Time frame: Baseline and 6 months after surgery

    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.

  2. Change in Sperm Concentration

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.

  3. Change in Total Sperm Count

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.

  4. Change in Progressive Sperm Motility

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.

  5. Change in Total Sperm Motility

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    Total sperm motility will be measured as the percentage of motile sperm on semen analysis.

  6. Change in Normal Sperm Morphology

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    Normal sperm morphology will be measured as the percentage of sperm with normal morphology on semen analysis.

  7. Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain

    Time frame: Baseline, 3 months, 6 months, and 12 months after surgery

    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.

  8. Number of Couples Achieving Spontaneous Pregnancy

    Time frame: Up to 12 months after surgery

    Spontaneous pregnancy in the female partner will be recorded during follow-up and reported separately from assisted reproductive technology-related pregnancy.

  9. Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy

    Time frame: Up to 12 months after surgery

    Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy.

  10. Operative time

    Time frame: Intraoperatively

    Operative time will be measured from skin incision to completion of wound closure.

  11. Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele

    Time frame: 12 months after surgery

    Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded.

  12. Number of Participants with Postoperative Complications

    Time frame: Up to 12 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed E Zahran, MD

CONTACT

[email protected]

+20 10 07950278 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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