Zonulin Levels in Varicocele Patients

NCT07748104 | Completed

• 1 other identifier: SUKAEK-2022 12/15
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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

Varicocele; Zonulin; Male Infertility

Keywords

Zonulin; Varicocele; Male infertility

Outcome Measures

Primary Outcomes (2)

• Serum and Seminal Zonulin Levels

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

  1 day

• Comparison of Semen Parameters Between Groups

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

  1 day

Study Arms (2)

Control

infertile men without varicocele

Varicocele

infertile men with varicocele

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: infertile men with or without varicocele
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had presented for infertility assessment were included in the study. Participants were divided into two groups: men with varicocele-related infertility and men with infertility without varicocele

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Süleyman Tümer Çalışkan: lead
• Samsun University: collaborator
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Gazi State Hospital

Samsun, İlkadım, Turkey (Türkiye)

Location

Related Publications (2)

• Kaltsas A, Zikopoulos A, Markou E, Zachariou A, Stavropoulos M, Kratiras Z, Symeonidis EN, Dimitriadis F, Sofikitis N, Chrisofos M. Proteomics and Metabolomics in Varicocele-Associated Male Infertility: Advancing Precision Diagnostics and Therapy. J Clin Med. 2024 Dec 4;13(23):7390. doi: 10.3390/jcm13237390.

  PMID: 39685846 BACKGROUND

• Moreno-Navarrete JM, Sabater M, Ortega F, Ricart W, Fernandez-Real JM. Circulating zonulin, a marker of intestinal permeability, is increased in association with obesity-associated insulin resistance. PLoS One. 2012;7(5):e37160. doi: 10.1371/journal.pone.0037160. Epub 2012 May 18.

  PMID: 22629362 BACKGROUND

MeSH Terms

Conditions

Varicocele; Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Officials

• Süleyman T Çalışkan

  Gazi State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: August 5, 2026
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)