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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed E Zahran, MD | Contact | +20 10 07950278 | +2 | Ahmed.ebrahim@fmed.bu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Banhā | Qalyubia Governorate | 13511 | Egypt |
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.
Data will be available beginning 6 months after publication of the main study results and will remain available for 3 years.
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.
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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.
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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.
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| 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. |
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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 |
| ID | Term |
|---|---|
| D014646 | Varicocele |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007246 | Infertility |
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