Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient.

Not Applicable

Recruiting

• Conditions: Varicocele
• Interventions: Drug: Fertitonex capsule; Drug: Placebo Oral Capsule

• Registration Number: NCT06718426
• Lead Sponsor: Menoufia University

Brief Summary

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 Timeline

• Study First Submitted: 2024-11-30
• Study Start: 2024-12-01
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-11-30
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

• Primary infertility.
• Abnormal semen analysis parameters.
• Clinically evident varicocele confirmed by scrotal duplex.

Exclusion Criteria

• 2ry infertility.
• Normal semen analysis parameters.
• Clinically non-evident varicocele.
• Past history of varicocelectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fertitonex group	Fertitonex capsule	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.
Placebo group	Placebo Oral Capsule	Patients in this group will receive placebo capsule twice daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Total sperm count	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	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	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.

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shebin El-Kom, Menoufia, Egypt