Infertility, MaleFERTILISNCT04193358
Impact of A Nutritional Supplements' Combination (FERTILIS) on Male Infertility
A study testing FERTILIS HOMME® in people with Infertility, Male and Subfertility, Male, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Infertility, Male, Subfertility, Male
- What is being tested?
- FERTILIS HOMME®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Feb 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Farhat Hached Hospital
Sousse
Mounir Ajina, MD
About this study
Official title: Impact of A Nutritional Supplements' Combination (FERTILIS) On Male Infertility: A Monocentric Double Blind Randomized Placebo Controlled Trial
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.
Read more
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
- Being tested
- FERTILIS HOMME®, PLACEBO
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PLACEBOOther
Sugar pills
| Study group | Role | What they receive |
|---|---|---|
| FERTILIS HOMME® group (group A) | Experimental | Group A will receive 2 FERTILIS HOMME capsules twice daily to be taken with meals for 3 months. Receives: 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 Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (9)
Sperm quantity
Ejaculatory volume (ml) and sperm cell density (mill/ml
Measured: 3 months
Sperm quality
Sperm morphology and sperm total motility/progressive motility
Measured: Up to 3 months
Occurrence of spontaneous pregnancy
Measured: Through study completion, an average of 2 years
Occurrence of pregnancy consecutive to Assisted Reproductive Technology (ART)
Measured: Through study completion, an average of 2 years
Fertilization rate during in vitro fertilization (IVF)
Measured: Up to 3 months
Embryo cleavage rate and embryo quality during intracytoplasmic sperm injection (ICSI)
Measured: Up to 3 months
Achievement of clinical pregnancy
Measured: Through study completion, an average of 2 years
Achievement of live birth
Measured: Through study completion, an average of 2 years
Number of Adverse Events
To assess the safety of the study product
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start17 Feb 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, interventional, prospective, monocentric, double blind, randomized, placebo controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mounir Ajina, Dr., Principal investigator, Farhat Hached HospitalLatifa Lassoued, Dr., Principal investigator, Farhat Hached Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193358
- Sponsor's protocol ID
- FERTILIS-349
- Acronym
- FERTILIS
- Status last verified
- Mar 2021
- First submitted
- 5 Dec 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of A Nutritional Supplements' Combination (FERTILIS) On Male Infertility: A Monocentric Double Blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04193358
- Acronym / sponsor ID
- FERTILIS / FERTILIS-349
- Conditions
- Infertility, Male, Subfertility, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative, interventional, prospective, monocentric, double blind, randomized, placebo controlled trial.
| Arm | Type | Receives |
|---|---|---|
| FERTILIS HOMME® group (group A) | Experimental | Dietary Supplement: FERTILIS HOMME®Group A will receive 2 FERTILIS HOMME capsules twice daily to be taken with meals for 3 months. |
| Placebo group (group B) | Placebo comparator | Other: PLACEBOGroup B will receive 2 placebo capsules twice daily to be taken with meals for 3 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | FERTILIS HOMME® group (group A) |
| PLACEBOSugar pills | Other | Placebo group (group B) |
Primary outcome
Sperm DNA fragmentation Index (DFI)
Time frame: 3 months
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).
9 secondary outcomes
Sperm quantity
Time frame: 3 months
Sperm quality
Time frame: Up to 3 months
Occurrence of spontaneous pregnancy
Time frame: Through study completion, an average of 2 years
Occurrence of pregnancy consecutive to Assisted Reproductive Technology (ART)
Time frame: Through study completion, an average of 2 years
Fertilization rate during in vitro fertilization (IVF)
Time frame: Up to 3 months
Embryo cleavage rate and embryo quality during intracytoplasmic sperm injection (ICSI)
Time frame: Up to 3 months
Achievement of clinical pregnancy
Time frame: Through study completion, an average of 2 years
Achievement of live birth
Time frame: Through study completion, an average of 2 years
Number of Adverse Events
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mounir Ajina, Dr. principal investigator
Farhat Hached Hospital
Latifa Lassoued, Dr. principal investigator
Farhat Hached Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FERTILIS HOMME® in people with Infertility, Male and Subfertility, Male, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amina Radoui, MSc (0021698709295, a.radoui@medis.com.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm DNA fragmentation Index (DFI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.