Effect of Varicocelectomy on Spermatogenic Cell Count and Semen Parameters

Official title

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

Overview

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

• Procedure Subinguinal 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.

Primary outcome measures

• Change in Seminal Spermatogenic Cell Count [Time frame: Preoperatively, and at 3 and 6 months postoperatively.]

Secondary outcome measures (1)

• Change in Sperm Concentration [Time frame: Preoperatively, and at 3 and 6 months postoperatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07684963 · Varicocelectomy & Semen Cells

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗