VaricoceleNCT06718426
Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient.
A study testing Fertitonex capsule in people with Varicocele, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Fertitonex capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Feb 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary infertility.
- Abnormal semen analysis parameters.
- Clinically evident varicocele confirmed by scrotal duplex.
Who cannot join
- 2ry infertility.
- Normal semen analysis parameters.
- Clinically non-evident varicocele.
- Past history of varicocelectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia Faculty of Medicine
Shebin El-Kom, Menoufia, 32511
Mustafa F Doctor, +201557586188, Moustafa.fathy@med.menofia.edu.eg
About this study
Official title: Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient, Placebo Controlled Study
The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.
Read the detailed description
Infertility is defined as the inability of a couple to conceive after one year of unprotected, frequent and regular sexual intercourse. Almost 15% of all couples trying to conceive are affected by infertility, and in almost half of these cases male infertility is the sole or a contributing factor. The most common cause is idiopathic oligoasthenoteratozoospermia (OAT) that is defined as follows sperm concentration, the proportion of morphologically normal sperm and the proportion of motile sperm are all lower than the World Health Organization (WHO) reference values.
Despite extensive research, a successful treatment for OAT had not yet been developed. Small amounts of reactive oxygen species (ROS) are produced by spermatozoa in physiological conditions, and various scavengers act to reduce the concentration of these ROS in the seminal plasma. ROS are needed for capacitation, acrosome reaction and ultimately fertilization.
Antioxidants might help maintain the balance between ROS production and clearance and thus could improve sperm quality Additionally, observational studies had found a lower frequency of sperm aneuploidy in men with a higher dietary intake of antioxidants than in those with a lower intake. In semen, antioxidants decrease OS, potentially improving sperm motility and reducing DNA fragmentation.
We aim to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.
- Conditions
- Varicocele
- Being tested
- Fertitonex capsule, Placebo Oral Capsule
- Keywords
- varicocele, Fertitonex, infertility, semen analysis
- Medical subject headings
- Varicocele, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertitonex capsuleDrug
Fertitonex which contains L- carnitine L-tartarate 300 mg, L-arginine 241mg, vitamin B6 1.1 mg, vitamin B12 1.7 mcg, vitamin D3 2 mcg, vitamin E 6.5 mg, vitamin C 60 mg, selenium 28 mcg, zinc 7.5 mg, folic acid 300 mcg and CoQ 10 enzyme 7.5 mg in each capsule. The dose will be one capsule twice daily for 3 months.
Placebo Oral CapsuleDrug
placebo oral capsule. the dose is twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Fertitonex group | Active comparator | Patients in this group will receive Fertitonex which contains L- carnitine L-tartarate 300 mg, L-arginine 241mg, vitamin B6 1.1 mg, vitamin B12 1.7 mcg, vitamin D3 2 mcg, vitamin E 6.5 mg, vitamin C 60 mg, selenium 28 mcg, zinc 7.5 mg, folic acid 300 mcg and CoQ 10 enzyme 7.5 mg in each capsule. The dose will be one capsule twice daily for 3 months. Receives: Drug: Fertitonex capsule |
| Placebo group | Placebo comparator | Patients in this group will receive placebo capsule twice daily for 3 months. Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sperm count
Total sperm count will be assessed by Semen analysis done after 3 months of either fertitonex or placebo administration.
Total sperm count will be measured by number of sperms present in the semen sample.
Measured: 3 months
Sperm motility
Sperm motility will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration.
Both total motility will be measured by percentage of motile sperms and progressive motility will be measured by percentage of progressively motile sperms present in the semen sample.
Measured: 3 months
Sperm Morphology
Sperm morphology will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration.
Sperm morphology will be measured by percentage of normally shaped sperms present in the semen sample.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718426
- Sponsor's protocol ID
- Fertitonex in varicocele
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06718426
- Acronym / sponsor ID
- Fertitonex in varicocele
- Conditions
- Varicocele
- Keywords
- varicocele, Fertitonex, infertility, semen analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 5 Dec 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 the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.
Detailed description
Infertility is defined as the inability of a couple to conceive after one year of unprotected, frequent and regular sexual intercourse. Almost 15% of all couples trying to conceive are affected by infertility, and in almost half of these cases male infertility is the sole or a contributing factor. The most common cause is idiopathic oligoasthenoteratozoospermia (OAT) that is defined as follows sperm concentration, the proportion of morphologically normal sperm and the proportion of motile sperm are all lower than the World Health Organization (WHO) reference values.
Despite extensive research, a successful treatment for OAT had not yet been developed. Small amounts of reactive oxygen species (ROS) are produced by spermatozoa in physiological conditions, and various scavengers act to reduce the concentration of these ROS in the seminal plasma. ROS are needed for capacitation, acrosome reaction and ultimately fertilization.
Antioxidants might help maintain the balance between ROS production and clearance and thus could improve sperm quality Additionally, observational studies had found a lower frequency of sperm aneuploidy in men with a higher dietary intake of antioxidants than in those with a lower intake. In semen, antioxidants decrease OS, potentially improving sperm motility and reducing DNA fragmentation.
We aim to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertitonex group | Active comparator | Drug: Fertitonex capsulePatients in this group will receive Fertitonex which contains L- carnitine L-tartarate 300 mg, L-arginine 241mg, vitamin B6 1.1 mg, vitamin B12 1.7 mcg, vitamin D3 2 mcg, vitamin E 6.5 mg, vitamin C 60 mg, selenium 28 mcg, zinc 7.5 mg, folic acid 300 mcg and CoQ 10 enzyme 7.5 mg in each capsule. The dose will be one capsule twice daily for 3 months. |
| Placebo group | Placebo comparator | Drug: Placebo Oral CapsulePatients in this group will receive placebo capsule twice daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary infertility.
- Abnormal semen analysis parameters.
- Clinically evident varicocele confirmed by scrotal duplex.
Key exclusion criteria (4 listed)
- 2ry infertility.
- Normal semen analysis parameters.
- Clinically non-evident varicocele.
- Past history of varicocelectomy.
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 |
|---|---|---|
| Fertitonex capsuleFertitonex which contains L- carnitine L-tartarate 300 mg, L-arginine 241mg, vitamin B6 1.1 mg, vitamin B12 1.7 mcg, vitamin D3 2 mcg, vitamin E 6.5 mg, vitamin C 60 mg, selenium 28 mcg, zinc 7.5 mg, folic acid 300 mcg and CoQ 10 enzyme 7.5 mg in each capsule. The dose will be one capsule twice daily for 3 months. | Drug | Fertitonex group |
| Placebo Oral Capsuleplacebo oral capsule. the dose is twice daily for 3 months | Drug | Placebo group |
Primary outcome
Total sperm count
Time frame: 3 months
Total sperm count will be assessed by Semen analysis done after 3 months of either fertitonex or placebo administration. Total sperm count will be measured by number of sperms present in the semen sample.
Sperm motility
Time frame: 3 months
Sperm motility will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration. Both total motility will be measured by percentage of motile sperms and progressive motility will be measured by percentage of progressively motile sperms present in the semen sample.
Sperm Morphology
Time frame: 3 months
Sperm morphology will be assessed by semen analysis done after 3 months of either fertitonex or placebo administration. Sperm morphology will be measured by percentage of normally shaped sperms present in the semen sample.
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 26 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertitonex capsule in people with Varicocele, run by Menoufia 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Mar 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. Some participants in this study may receive a placebo. 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?
Contact Ammar F Alorabi (+201067608011, ammar.alorabi95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sperm count (time frame: 3 months). The study lists 3 primary outcomes in all. 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 26 Mar 2025.