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

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.

Study Overview

• Status: Recruiting
• Conditions: Varicocele
• Intervention / Treatment: Drug: Fertitonex capsule; Drug: Placebo Oral Capsule

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ammar F Alorabi; Phone Number: +201067608011; Email: ammar.alorabi95@gmail.com

Study Locations

• Egypt
  • Menoufia
    • Shebin El-Kom, Menoufia, Egypt, 32511
      • Recruiting
      • Menoufia Faculty of Medicine
      • Contact: Mustafa F Doctor; Phone Number: +201557586188; Email: Moustafa.fathy@med.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fertitonex group; 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; 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 Comparator: Placebo group; Patients in this group will receive placebo capsule twice daily for 3 months.	Drug: Placebo Oral Capsule; placebo oral capsule. the dose is twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: infertility; semen analysis; varicocele; Fertitonex
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Diseases, Male; Male Urogenital Diseases; Varicocele
• Other Study ID Numbers: Fertitonex in varicocele

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No