Zonulin Levels in Varicocele Patients | NCT07748104

NCT07748104

Overview

NCT ID: NCT07748104
Lead Sponsor: Süleyman Tümer ÇalışkanOTHER
Official Title: Evaluation of Serum and Seminal Zonulin Levels in Infertile Men With Varicocele
Brief Summary: This prospective cross-sectional observational study was designed to evaluate serum and seminal plasma zonulin levels in infertile men with clinically diagnosed varicocele and compare them with those in infertile men without varicocele. The study also aimed to investigate the association between zonulin concentrations and conventional semen parameters.

A total of 119 men evaluated for infertility between December 2022 and May 2023 were included. Participants were classified into two groups according to the presence or absence of clinically diagnosed varicocele. Serum and seminal plasma zonulin concentrations were measured using enzyme-linked immunosorbent assay (ELISA). Conventional semen parameters, including semen volume, sperm concentration, total sperm count, progressive motility, total motility, and normal sperm morphology, were evaluated and compared between the study groups.
Conditions

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male patients aged 18 to 50 years.

Infertility requiring semen analysis.

No history of systemic disease.

Non-smokers and non-cannabis users.

No use of medications that could affect semen parameters within the previous 3 months.

Body mass index (BMI) between 20 and 30 kg/m².

Exclusion Criteria:

Presence of any chronic systemic disease.

Signs or symptoms of active infection.

Tobacco smoking or cannabis use.

Illicit drug use.

Use of medications that could affect semen parameters within the previous 3 months.

Clinical findings suggestive of prostatitis or urethritis (elevated white blood cell count on semen analysis).

Body mass index (BMI) <20 kg/m² or >30 kg/m².

Leukocyte concentration >1 × 10⁶ cells/mL in semen, indicative of a possible genital tract infection.

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