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

NCT04193358 | Unknown DMC

• 1 other identifier: FERTILIS-349
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sperm DNA fragmentation Index (DFI)

  To evaluate the effect of a nutritional supplement's combination of 8 active compounds (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; FERTILIS HOMME®, Les Laboratoires MédiS, Tunisia), on sperm DNA fragmentation index (DFI).

  3 months

Secondary Outcomes (9)

• Sperm quantity

  3 months

• Sperm quality

  Up to 3 months

• Occurrence of spontaneous pregnancy

  Through study completion, an average of 2 years

• Occurrence of pregnancy consecutive to Assisted Reproductive Technology (ART)

  Through study completion, an average of 2 years

• Fertilization rate during in vitro fertilization (IVF)

  Up to 3 months

Study Arms (2)

FERTILIS HOMME® group (group A)

EXPERIMENTAL

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

Dietary Supplement: FERTILIS HOMME®

Placebo group (group B)

PLACEBO COMPARATOR

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

Other: PLACEBO

Interventions

FERTILIS HOMME® 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

FERTILIS HOMME® group (group A)

PLACEBO OTHER

Sugar pills

Placebo group (group B)

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

Farhat Hached Hospital

Sousse, Tunisia

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Mounir Ajina, Dr.

  Farhat Hached Hospital

  PRINCIPAL INVESTIGATOR

• Latifa Lassoued, Dr.

  Farhat Hached Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amina Radoui, MSc

CONTACT

0021698709295; a.radoui@medis.com.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, interventional, prospective, monocentric, double blind, randomized, placebo controlled trial.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: February 17, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-03

Locations

TU (1)