Effect of Varicocelectomy on Spermatogenic Cell Count and Semen Parameters

NCT07684963 | Not Yet Recruiting

• 1 other identifier: Varicocelectomy & Semen Cells
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate how varicocele surgery (varicocelectomy) affects the number of immature sperm cells (spermatogenic cells) found in the semen of infertile men. Varicocele, an abnormal dilation of veins in the scrotum, is a common cause of male infertility that can negatively impact semen quality and overall testicular function. While surgery is widely performed to improve standard semen parameters, this study specifically investigates its impact on the shedding of immature germ cells into the seminal fluid, which can be an indicator of impaired sperm production. Researchers will enroll 40 infertile married men, aged 20 to 45, who have been diagnosed with a clinical varicocele and exhibit abnormal semen parameters. All participants will undergo a single surgical intervention known as a subinguinal microsurgical varicocelectomy. To measure the effects of the surgery, participants will undergo careful semen analysis before the procedure, and again at 3 and 6 months postoperatively. The primary goal is to track changes in the spermatogenic cell count and abnormal sperm morphology, and to explore how these changes correlate with conventional semen parameters like sperm concentration, motility, and vitality.

Conditions

Varicocele; Infertility; Varicocelectomy; Male Infertility

Keywords

Spermatogenic Cells; Semen Parameters; Immature Germ Cells; Semen Analysis; Sperm Morphology; Round Cells

Outcome Measures

Primary Outcomes (1)

• Change in Seminal Spermatogenic Cell Count

  Spermatogenic cell concentration will be quantified using a Neubauer hemocytometer and expressed as x10⁶ cells/mL.

  Preoperatively, and at 3 and 6 months postoperatively.

Secondary Outcomes (1)

• Change in Sperm Concentration

  Preoperatively, and at 3 and 6 months postoperatively.

Study Arms (1)

Microsurgical Varicocelectomy

EXPERIMENTAL

Infertile married males aged 20-45 with clinical varicocele and abnormal semen parameters will form a single study arm. All participants will undergo a subinguinal microsurgical varicocelectomy. The surgical technique involves opening the spermatic fasciae under microscopic magnification (up to 10X), identifying and preserving the internal spermatic artery, and ligating the internal spermatic and cremasteric veins. Semen analysis, including spermatogenic cell quantification using combined morphological and enzymatic methods, will be conducted preoperatively and at 3 and 6 months postoperatively.

Procedure: Subinguinal Microsurgical Varicocelectomy

Interventions

Subinguinal Microsurgical Varicocelectomy PROCEDURE

A 3-4 cm subinguinal incision will be made below the external ring. Under 5-10X microscopic magnification, the internal spermatic artery will be identified and preserved. The internal spermatic veins and cremasteric veins, with the exception of vasal veins, will be ligated. The testicular arteries, cremasteric arteries, cremaster muscle fibers, nerves, lymphatic vessels, and vas deferens will be preserved before the spermatic cord is returned and the incision is closed.

Microsurgical Varicocelectomy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile married males diagnosed with clinical varicocele.
• Age between 20-45 years.
• Patients indicated for varicocelectomy according to standard clinical guidelines.
• Abnormal or suboptimal semen parameters on at least two semen analyses.

You may not qualify if:

• Azoospermic patients (complete absence of sperm in semen).
• History of previous varicocelectomy or scrotal surgery.
• Presence of other known causes of infertility (e.g., genetic abnormalities, obstructive azoospermia).
• Active genital infection or systemic infection affecting semen analysis.
• Use of medications affecting spermatogenesis within the last 3 months (e.g., testosterone, chemotherapy).
• Chronic systemic diseases known to affect fertility (e.g., uncontrolled diabetes, liver failure).
• Severe leukocytospermia as confirmed by peroxidase (Endtz) test exceeding WHO reference limits.
• Pus cell \> 1 million/ml by peroxidase.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Varicocele; Infertility, Male; Infertility

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Andrology and Sexology and STDs, Assiut University

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06