Gut protein zonulin: a hidden clue to male infertility?
NCT ID NCT07748104
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This study looks at whether levels of a protein called zonulin, found in blood and semen, differ between infertile men with and without varicocele (enlarged veins in the scrotum). Researchers will measure zonulin in 119 men and compare it with standard semen quality measures like sperm count and movement. The goal is to see if zonulin could serve as a marker for infertility in men with varicocele.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If a link is found, zonulin might become a marker to help diagnose or understand male infertility related to varicocele.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The findings may not apply to all men with varicocele.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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119 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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May 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gazi State Hospital
Samsun, İlkadım, Turkey (Türkiye)
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