Impact of A Nutritional Supplements' Combination (FERTILIS) on Male Infertility (FERTILIS)
Primary Purpose
Infertility, Male, Subfertility, Male
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
FERTILIS HOMME®
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male
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:
- Inclusion visit (prior to treatment initiation): Patients will be selected during this initial visit if they meet all inclusion and none of the 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.
Sites / Locations
- Farhat Hached HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FERTILIS HOMME® group (group A)
Placebo group (group B)
Arm Description
Group A will receive 2 FERTILIS HOMME capsules twice daily to be taken with meals for 3 months.
Group B will receive 2 placebo capsules twice daily to be taken with meals for 3 months
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Sperm quantity
Ejaculatory volume (ml) and sperm cell density (mill/ml
Sperm quality
Sperm morphology and sperm total motility/progressive motility
Occurrence of spontaneous pregnancy
Occurrence of pregnancy consecutive to Assisted Reproductive Technology (ART)
Fertilization rate during in vitro fertilization (IVF)
Embryo cleavage rate and embryo quality during intracytoplasmic sperm injection (ICSI)
Achievement of clinical pregnancy
Achievement of live birth
Number of Adverse Events
To assess the safety of the study product
Full Information
NCT ID
NCT04193358
First Posted
December 5, 2019
Last Updated
July 27, 2021
Sponsor
Les Laboratoires des Médicaments Stériles
1. Study Identification
Unique Protocol Identification Number
NCT04193358
Brief Title
Impact of A Nutritional Supplements' Combination (FERTILIS) on Male Infertility
Acronym
FERTILIS
Official Title
Impact of A Nutritional Supplements' Combination (FERTILIS) On Male Infertility: A Monocentric Double Blind Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Les Laboratoires des Médicaments Stériles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, Subfertility, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative, interventional, prospective, monocentric, double blind, randomized, placebo controlled trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FERTILIS HOMME® group (group A)
Arm Type
Experimental
Arm Description
Group A will receive 2 FERTILIS HOMME capsules twice daily to be taken with meals for 3 months.
Arm Title
Placebo group (group B)
Arm Type
Placebo Comparator
Arm Description
Group B will receive 2 placebo capsules twice daily to be taken with meals for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
FERTILIS HOMME®
Intervention Description
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
Other
Intervention Name(s)
PLACEBO
Intervention Description
Sugar pills
Primary Outcome Measure Information:
Title
Sperm DNA fragmentation Index (DFI)
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sperm quantity
Description
Ejaculatory volume (ml) and sperm cell density (mill/ml
Time Frame
3 months
Title
Sperm quality
Description
Sperm morphology and sperm total motility/progressive motility
Time Frame
Up to 3 months
Title
Occurrence of spontaneous pregnancy
Time Frame
Through study completion, an average of 2 years
Title
Occurrence of pregnancy consecutive to Assisted Reproductive Technology (ART)
Time Frame
Through study completion, an average of 2 years
Title
Fertilization rate during in vitro fertilization (IVF)
Time Frame
Up to 3 months
Title
Embryo cleavage rate and embryo quality during intracytoplasmic sperm injection (ICSI)
Time Frame
Up to 3 months
Title
Achievement of clinical pregnancy
Time Frame
Through study completion, an average of 2 years
Title
Achievement of live birth
Time Frame
Through study completion, an average of 2 years
Title
Number of Adverse Events
Description
To assess the safety of the study product
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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:
Inclusion visit (prior to treatment initiation): Patients will be selected during this initial visit if they meet all inclusion and none of the 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amina Radoui, MSc
Phone
0021698709295
Email
a.radoui@medis.com.tn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mounir Ajina, Dr.
Organizational Affiliation
Farhat Hached Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Latifa Lassoued, Dr.
Organizational Affiliation
Farhat Hached Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farhat Hached Hospital
City
Sousse
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mounir Ajina, MD
12. IPD Sharing Statement
Learn more about this trial
Impact of A Nutritional Supplements' Combination (FERTILIS) on Male Infertility
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