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Effect of Varicocelectomy on Spermatogenic Cell Count and Semen Parameters

Seminal Spermatogenic Cell Count Pre and Post Varicocelectomy: Relation to Seminal Parameters

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07684963
Enrollment
40
Registered
2026-07-06
Start date
2026-08-01
Completion date
2027-09-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male Infertility, Varicocele, Varicocelectomy

Keywords

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

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.

Detailed description

Male factor infertility contributes as the sole factor in approximately 20-25% of infertile couples. While semen analysis remains the cornerstone for evaluating male infertility , conventional parameters may not fully reflect underlying functional and molecular alterations. Varicocele, characterized by abnormal dilatation and tortuosity of the pampiniform venous plexus, is one of the most common correctable causes of male infertility. The pathological changes associated with varicocele can adversely affect the seminiferous epithelium, leading to defective spermatogenesis and an increased sloughing of immature germ cells (spermatogenic cells) into the seminal fluid. According to World Health Organization (WHO) recommendations, the presence of these spermatogenic cells is clinically relevant as it reflects impaired spermatogenesis and testicular dysfunction. This prospective interventional study aims to evaluate changes in seminal spermatogenic cell counts and conventional semen parameters following surgical correction. Participants will undergo a subinguinal microsurgical varicocelectomy. During the procedure, the spermatic cord is delivered and examined under 5-10X microscopic magnification. The internal spermatic artery is carefully identified, utilizing an intraoperative USG probe if necessary, and dissected free of surrounding structures. Internal spermatic veins and cremasteric veins are ligated, while testicular arteries, cremasteric arteries, lymphatic vessels, and the vas deferens are preserved. To assess the surgical outcomes, semen samples will be collected after 3-5 days of sexual abstinence preoperatively (at least a week apart, utilizing the second sample) and postoperatively at 3 and 6 months. The differentiation of seminal round cells into leukocytes and spermatogenic cells will be conducted using combined morphological and enzymatic methods. Semen smears will be stained with Papanicolaou stain and examined under light microscopy to identify spermatogenic cells based on nuclear morphological features. A peroxidase (Endtz) test will concurrently be used to differentiate peroxidase-positive leukocytes from peroxidase-negative spermatogenic cells. The spermatogenic cell concentration will be quantified using a Neubauer hemocytometer according to the WHO 2021 manual equation.

Interventions

PROCEDURESubinguinal Microsurgical Varicocelectomy

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Seminal Spermatogenic Cell CountPreoperatively, and at 3 and 6 months postoperatively.Spermatogenic cell concentration will be quantified using a Neubauer hemocytometer and expressed as x10⁶ cells/mL.

Secondary

MeasureTime frameDescription
Change in Sperm ConcentrationPreoperatively, and at 3 and 6 months postoperatively.The change in sperm concentration will be analyzed and measured in 10⁶/ml according to the World Health Organization (WHO) Laboratory Manual.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026