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

Last updated: March 23, 2025
Sponsor: Menoufia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Male Hormonal Deficiencies/abnormalities

Treatment

Placebo Oral Capsule

Fertitonex capsule

Clinical Study ID

NCT06718426
Fertitonex in varicocele
  • Ages > 18
  • Male

Study Summary

The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary infertility.

  • Abnormal semen analysis parameters.

  • Clinically evident varicocele confirmed by scrotal duplex.

Exclusion

Exclusion Criteria:

  • 2ry infertility.

  • Normal semen analysis parameters.

  • Clinically non-evident varicocele.

  • Past history of varicocelectomy.

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Placebo Oral Capsule
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • Menoufia Faculty of Medicine

    Shebin El-Kom, Menoufia 32511
    Egypt

    Active - Recruiting

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