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Clinical Trials/NCT07748104
NCT07748104CompletedNot Applicable

Evaluation of Serum and Seminal Zonulin Levels in Infertile Men With Varicocele

Süleyman Tümer Çalışkan1 site in 1 country119 target enrollmentStarted: December 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
119
Locations
1
Primary Endpoint
Serum and Seminal Zonulin Levels

Study Overview

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.

Detailed Description

Varicocele is one of the most common causes of male infertility and is associated with impaired spermatogenesis through multiple mechanisms, including oxidative stress, inflammation, and disruption of testicular microcirculation. Zonulin, a physiological regulator of epithelial tight junctions, has been proposed as a biomarker of increased intestinal permeability and systemic inflammation. However, the relationship between serum and seminal plasma zonulin levels and varicocele in infertile men has not been fully investigated.

This prospective 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 was also designed to examine the association between zonulin concentrations and conventional semen parameters, including semen volume, sperm concentration, total sperm count, progressive motility, total motility, and normal sperm morphology.

A total of 119 infertile men presenting to the Urology outpatient clinic between December 2022 and May 2023 were enrolled. Participants were assigned to groups according to the presence or absence of clinically diagnosed varicocele. Patients with systemic diseases, active infections, tobacco or cannabis use, use of medications known to affect semen parameters, abnormal body mass index, or evidence of genital tract infection were excluded. Serum and seminal plasma samples were collected on the day of semen analysis, and zonulin concentrations were measured using enzyme-linked immunosorbent assay (ELISA).

The primary objective was to compare serum and seminal plasma zonulin levels between infertile men with and without varicocele. Secondary objectives were to evaluate the association between zonulin concentrations and conventional semen parameters.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control

infertile men without varicocele

Varicocele

infertile men with varicocele

Outcomes

Primary Outcomes

Serum and Seminal Zonulin Levels

Time Frame: 1 day

Assessment and comparison of serum and seminal zonulin concentrations in infertile men with varicocele and infertile men without varicocele.

Comparison of Semen Parameters Between Groups

Time Frame: 1 day

Assessment and comparison of semen parameters between infertile men with varicocele and infertile men without varicocele

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Süleyman Tümer Çalışkan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Süleyman Tümer Çalışkan

Specialist

Gazi State Hospital

Study Sites (1)

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