An interventional study of Fertitonex capsule and Placebo Oral Capsule in Varicocele, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 110 is above the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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.
Drug: Fertitonex capsule
Patients in this group will receive placebo capsule twice daily for 3 months.
Drug: Placebo Oral Capsule
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 capsule. the dose is twice daily for 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Started Dec 2024 (actual). Primary completion is estimated for Nov 2025, 11 months after the start.
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