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NCT Number: NCT06718426

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

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location status: Recruiting

Location contact

Mustafa F Doctor

CONTACT

[email protected]

+201557586188

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fertitonex capsule

Drug

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

Drug

placebo oral capsule. the dose is twice daily for 3 months

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ammar F Alorabi

CONTACT

[email protected]

+201067608011

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient, Placebo Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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