Impact of A Nutritional Supplements' Combination (FERTILIS) on Male Infertility

NCT ID: NCT04193358

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2022-12-30

Brief Summary

Infertility is a major health problem affecting up to 15% of couples of reproductive age globally. For several years, it was assumed that most reproductive problems could be attributed to the female partner, but research in recent years has demonstrated that males were solely responsible for 20-30% of infertility cases and contributed to 50% of infertility cases overall. The term ''male infertility'' does not constitute a defined clinical syndrome, but rather a collection of different conditions exhibiting a variety of etiologies.

It is far increasingly known that reactive oxygen species (ROS) are of significant pathophysiological importance in the etiology of male infertility. ROS are highly reactive oxidizing agents belonging to the class of free radicals containing one or more unpaired electrons, which are continuously being generated through metabolic and pathophysiologic processes. It has been suggested that oxidants interfere with normal sperm function via membrane lipid peroxidation and fragmentation of nucleic acids, which result in sperm dysfunction. Due to the sperm cell membrane abundance of polyunsaturated fatty acids (PUFAs) and the capacity of sperm to generate ROS, human spermatozoa are highly susceptible to oxidative stress.

Since growing evidence indicates that oxidative stress can be a primary cause of male infertility, non-enzymatic antioxidants play a significant protective role against oxidative damages and lipid peroxidation. In addition, micronutrients and antioxidants are often used with good results in men with idiopathic infertility.

Keeping in view the main protection provided by seminal plasma antioxidants against oxidative damages, a previous study showed that the dietary management with an eight nutritional supplements' combination, similar to this study's product and containing antioxidants, achieved a significant improvement in sperm quality up to a completely normal semen analysis. Also, another study confirmed the hypothesis that the combination of individual nutritional supplements as described in literature showed significantly better results than the sum of the effects of single administration.

Conditions

Infertility, Male; Subfertility, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FERTILIS HOMME® group (group A)

Group A will receive 2 FERTILIS HOMME capsules twice daily to be taken with meals for 3 months.

Group Type: EXPERIMENTAL

FERTILIS HOMME®

Intervention Type: DIETARY_SUPPLEMENT

L-carnitine 220 mg, Zinc 20 mg, Selenium 0.03 mg, L-arginine 125 mg, L-glutathione 40 mg, Folic acid (vitamin B-9) 0.4 mg, Coenzyme Q10 7.5 mg, and Vitamin E 60 mg

Placebo group (group B)

Group B will receive 2 placebo capsules twice daily to be taken with meals for 3 months

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: OTHER

Sugar pills

Interventions

FERTILIS HOMME®

L-carnitine 220 mg, Zinc 20 mg, Selenium 0.03 mg, L-arginine 125 mg, L-glutathione 40 mg, Folic acid (vitamin B-9) 0.4 mg, Coenzyme Q10 7.5 mg, and Vitamin E 60 mg

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

Sugar pills

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male ≥ 20 years of age
• Attending the Department of Obstetrics and Gynecology of Farhat Hached University Hospital, Sousse, Tunisia, for consultation or semen analysis as part of infertility investigations
• Diagnosis of oligozoospermia (WHO 2010 definition)
• Diagnosis of Asthenozoospermia (WHO 2010 definition)
• Diagnosis of teratozoospermia1 (WHO 2010 definition)
• Diagnosis of idiopathic infertility
• Couple is candidate for Intrauterine Insemination (IUI), In Vitro Fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI).

Exclusion Criteria

• Randomization visit: around 1-week post inclusion visit: Patients will be given either of study interventions.
• Follow up visit 1-month post treatment initiation: Patients will be given study interventions' refill for 1 month.
• Follow up visit 2-months post treatment initiation: Patients will be given study interventions' refill for another month.
• Follow up visit 3-months post treatment initiation: Patients will undergo laboratory assessment.
• Follow up visits every 3-months post Visit: Patients' female partner will undergo laboratory and clinical assessment.
• End of trial (CLOSING) visit 24-months post treatment initiation: Patients' female partner will undergo laboratory and clinical assessment.

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Les Laboratoires des Médicaments Stériles

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mounir Ajina, Dr.

Role: PRINCIPAL_INVESTIGATOR

Farhat Hached Hospital

Latifa Lassoued, Dr.

Role: PRINCIPAL_INVESTIGATOR

Farhat Hached Hospital

Locations

Farhat Hached Hospital

Sousse, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Amina Radoui, MSc

Role: CONTACT

a.radoui@medis.com.tn

0021698709295

Facility Contacts

Mounir Ajina, MD

Role: primary

Other Identifiers

FERTILIS-349

Identifier Type: -

Identifier Source: org_study_id