Fertility IssuesNCT06478199
PLR and NLR as Predictor Factors for Semen Abnormality
An observational study of Fertility Issues, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- semen analysis
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient correlat to inclusion criteria
Who may be able to join
- adult above 18 years primary not do varicocelectomy
Who cannot join
- young secondry infertility recurrent varicocele
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.
- Conditions
- Fertility Issues
- Being tested
- semen analysis
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen analysisDiagnostic test
Also called cbc
lab invesigation
| Study group | Role | What they receive |
|---|---|---|
| Group A :normal semen | Not described Receives: Diagnostic Test: semen analysis | |
| Group B : abnormal semen | Not described Receives: Diagnostic Test: semen analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory result
cbc and semen analysis
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 posted27 Jun 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478199
- Sponsor's protocol ID
- semen paramaters
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLR and NLR as Predictor Factors for Semen Abnormality
- ClinicalTrials.gov ID
- NCT06478199
- Acronym / sponsor ID
- semen paramaters
- Conditions
- Fertility Issues
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Jun 2024 (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.
The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A :normal semen | – | Diagnostic Test: semen analysis |
| Group B : abnormal semen | – | Diagnostic Test: semen analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient correlat to inclusion criteria
Key inclusion criteria (1 listed)
- adult above 18 years primary not do varicocelectomy
Key exclusion criteria (1 listed)
- young secondry infertility recurrent varicocele
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semen analysisAlso: cbclab invesigation | Diagnostic test | Group A :normal semen, Group B : abnormal semen |
Primary outcome
Laboratory result
Time frame: 1 day
cbc and semen analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fertility Issues, run by Kafrelsheikh University at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Laboratory result (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.