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

Menoufia University

Status: Enrolling

Conditions: Varicocele

Treatments: Drug: Fertitonex capsule; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06718426

Fertitonex in varicocele

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups, including a placebo group

Fertitonex group

Active Comparator group

Description:

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.

Treatment:

Drug: Fertitonex capsule

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Capsule