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

NCT ID: NCT06718426

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Varicocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fertitonex capsule

Intervention Type 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 group

Patients in this group will receive placebo capsule twice daily for 3 months.

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo Oral Capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Ammar Fathi Mohamed AlOrabi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ammar F Alorabi

Role: CONTACT

+201067608011

Facility Contacts

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Mustafa F Doctor

Role: primary

+201557586188

Other Identifiers

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Fertitonex in varicocele

Identifier Type: -

Identifier Source: org_study_id

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