Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping, Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation.
- Who it may be relevant to
- Registry conditions: Varicocele, Male Infertility. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Persistent or Recurrent Varicocele on the Operated Side [Time frame: 12 months after surgery]
Secondary outcome measures (12)
- Change in Total Motile Sperm Count [Time frame: Baseline and 6 months after surgery]
- Change in Sperm Concentration [Time frame: Baseline, 3 months, 6 months, and 12 months after surgery]
- Change in Total Sperm Count [Time frame: Baseline, 3 months, 6 months, and 12 months after surgery]
- Change in Progressive Sperm Motility [Time frame: Baseline, 3 months, 6 months, and 12 months after surgery]
- Change in Total Sperm Motility [Time frame: Baseline, 3 months, 6 months, and 12 months after surgery]
- Change in Normal Sperm Morphology [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 [Time frame: Baseline, 3 months, 6 months, and 12 months after surgery]
- Number of Couples Achieving Spontaneous Pregnancy [Time frame: Up to 12 months after surgery]
- Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy [Time frame: Up to 12 months after surgery]
- Operative time [Time frame: Intraoperatively]
- Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele [Time frame: 12 months after surgery]
- Number of Participants with Postoperative Complications [Time frame: Up to 12 months after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Benha University Hospital — Banhā
Identifiers
NCT: NCT07605351 · RC 12-4-2025