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

NCT06718426 | Recruiting

• 1 other identifier: Fertitonex in varicocele
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Varicocele

Keywords

varicocele; Fertitonex; infertility; semen analysis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Fertitonex group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

Interventions

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.

Fertitonex group

Placebo Oral Capsule DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary infertility.
• Abnormal semen analysis parameters.
• Clinically evident varicocele confirmed by scrotal duplex.

You may not qualify if:

• ry infertility.
• Normal semen analysis parameters.
• Clinically non-evident varicocele.
• Past history of varicocelectomy.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Varicocele; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ammar F Alorabi

CONTACT

+201067608011; ammar.alorabi95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: February 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)