VaricoceleVARIZONNCT07748104
Zonulin Levels in Varicocele Patients
An observational study of Varicocele and Male Infertility, run by Süleyman Tümer Çalışkan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Varicocele, Male Infertility, Zonulin
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 May 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum and Seminal Zonulin Levels in Infertile Men With Varicocele
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.
Read the 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.
- Conditions
- Varicocele, Male Infertility, Zonulin
- Keywords
- Zonulin, Varicocele, Male infertility
- Medical subject headings
- Varicocele, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | infertile men without varicocele | |
| Varicocele | infertile men with varicocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and Seminal Zonulin Levels
Assessment and comparison of serum and seminal zonulin concentrations in infertile men with varicocele and infertile men without varicocele.
Measured: 1 day
Comparison of Semen Parameters Between Groups
Assessment and comparison of semen parameters between infertile men with varicocele and infertile men without varicocele
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Süleyman Tümer Çalışkan
- Sponsor type
- University, hospital or other
- Collaborators
- Samsun University, Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Süleyman Tümer Çalışkan, Gazi State Hospital
- Investigators
- Süleyman T Çalışkan, Principal investigator, Gazi State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748104
- Sponsor's protocol ID
- SUKAEK-2022 12/15
- Acronym
- VARIZON
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns. Data access is restricted to the study investigators in accordance with institutional regulations.
Publications
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.
PubMed 39685846Moreno-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.
PubMed 22629362
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum and Seminal Zonulin Levels in Infertile Men With Varicocele
- ClinicalTrials.gov ID
- NCT07748104
- Acronym / sponsor ID
- VARIZON / SUKAEK-2022 12/15
- Conditions
- Varicocele, Male Infertility, Zonulin
- Keywords
- Zonulin, Varicocele, Male infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Süleyman Tümer ÇalışkanUniversity, hospital or other
- Collaborators
- Samsun University, Ondokuz Mayıs University
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –infertile men without varicocele |
| Varicocele | – | –infertile men with varicocele |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 39685846Kaltsas 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.
- Background: PubMed 22629362Moreno-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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns. Data access is restricted to the study investigators in accordance with institutional regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Süleyman T Çalışkan principal investigator
Gazi State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele and Male Infertility, run by Süleyman Tümer Çalışkan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and Seminal Zonulin Levels (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07748104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.