Male Infertility, Varicocele
Conditions
Keywords
Varicocele, Male Infertility, Microsurgical Varicocelectomy, Subinguinal Varicocelectomy, Venous Stripping, Semen Analysis, Scrotal Doppler Ultrasound, Varicocele Recurrence, Abnormal Semen Parameters, Pregnancy Outcome
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.
Interventions
PROCEDUREMicrosurgical 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.
PROCEDUREStandard 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent or Recurrent Varicocele on the Operated Side | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Motile Sperm Count | 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. |
| Change in Sperm Concentration | 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. |
| Change in Total Sperm Count | 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. |
| Change in Progressive Sperm Motility | 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. |
| Change in Total Sperm Motility | 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. |
| Change in Normal Sperm Morphology | 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. |
| Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain | 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. |
| Number of Couples Achieving Spontaneous Pregnancy | 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. |
| Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy | Up to 12 months after surgery | Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy. |
| Operative time | Intraoperatively | Operative time will be measured from skin incision to completion of wound closure. |
| Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele | 12 months after surgery | Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded. |
| Number of Participants with Postoperative Complications | 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. |
Countries
Egypt
Contacts
CONTACTAhmed E Zahran, MD
Outcome results
None listed