Male InfertilityFabLifeNCT03475199
Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement
A study testing FabLife in people with Male Infertility, run by FabLife at 2 sites in France.
Trial summary
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France. The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- FabLife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2018to Dec 2019
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary infertility greater than 12 months
- Conventional spermatic parameters compatible with spontaneous pregnancy
- Sperm Count> 5M / ml and
- Progressive sperm mobility> 20%
- Negative spermoculture
- Fragmentation of sperm DNA> 20%
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- Patient able to understand dietary recommendations given in French, in writing and orally
- Social insured patient receiving benefits from the French Social Security health branch
- Patient with a mobile phone (iOS or Android) with internet access
Who cannot join
- Patient diagnosed with severe oligospermia (<5 million spz / ejaculate)
- Patient with BMI> 35 or <18.5
- Patient with known and treated diabetes
- Patient with known and treated lipid disorders
- Patient with known and treated cardiovascular diseases
- Patients with known and treated hypertension
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- Patients with known and treated dysthyroidism
- Patients with known symptomatic varicocele
- Patient with known inflammatory bowel diseases
- Patient with renal failure diagnosed
- Patient presenting a viral risk (HIV / Hepatitis B and C / ...) requiring support in a dedicated circuit
- Patient unable to give informed consent
- Minors and protected adults, vulnerable people
- Patient participating in another clinical research study
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Drouot Laboratory
Paris, 75009
Cassuto Guy, Dr
Dominique MAUGET-BOURET, Dr
- Not yet recruiting
Tenon Hospital (AP-HP)
Paris, 75019
Rachel LEVY, +331 56 01 70 02, rachel.levy@aphp.fr
Rachel LEVY, Pr
About this study
Official title: Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.
The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.
Read the detailed description
More than 15 % of couples couldn't get pregnant after at least a year of unprotected intercourse.
The FabLife personalised program aims to improve sperm quality including sperm DNA fragmentation in subfertile men through:
- A personalized dietary program based on patient's phenotype and genotype
- A daily dietary supplement, developed in the context of male infertility
A total of 75 patients will be recruited:
- 46 patients will benefit from the program,
- 23 patients will form the control group.
- 6 patients will not answer to all the criteria.
- Conditions
- Male Infertility
- Being tested
- FabLife
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FabLifeDevice
- A personnalized dietary program depending on the patient's phenotype and genotype
- The daily intake of a dietary supplement, developped in the context of male infertility.
| Study group | Role | What they receive |
|---|---|---|
| FabLife group | Experimental | Fablife personnalised support and telephone follow-up with a dietician. Receives: Device: FabLife |
| Control group | No intervention | General dietary recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA fragmentation
Difference in sperm DNA fragmentation from baseline to post-treatment
Measured: 15 weeks
Secondary outcomes (6)
Semen quality
Difference in semen quality (semen variables including total sperm count, sperm concentration, sperm motility, sperm morphology and semen volume) from baseline to post-treatment.
Measured: 15 weeks
Sperm motility
Difference in sperm motility from baseline to post-treatment.
Measured: 15 weeks
Sperm morphology
Difference in sperm morphology from baseline to post-treatment.
Measured: 15 weeks
Sperm concentration
Difference in sperm concentration from baseline to post-treatment.
Measured: 15 weeks
Semen volume
Difference in semen volume from baseline to post-treatment.
Measured: 15 weeks
Total sperm count
Difference in total sperm count from baseline to post-treatment.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start13 Feb 2018
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicentric, controlled, national study
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FabLife
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma
- Responsible party
- Sponsor
- Investigators
- Rachel Levy, Md, PhD, Pr, Principal investigator, Hopital Tenon (AP-HP) France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475199
- Sponsor's protocol ID
- 2017-AO3218-45
- Acronym
- FabLife
- Status last verified
- Feb 2019
- First submitted
- 12 Mar 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility
- ClinicalTrials.gov ID
- NCT03475199
- Acronym / sponsor ID
- FabLife / 2017-AO3218-45
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- FabLifeIndustry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Mar 2018 (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.
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.
The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.
Detailed description
More than 15 % of couples couldn't get pregnant after at least a year of unprotected intercourse.
The FabLife personalised program aims to improve sperm quality including sperm DNA fragmentation in subfertile men through:
- A personalized dietary program based on patient's phenotype and genotype
- A daily dietary supplement, developed in the context of male infertility
A total of 75 patients will be recruited:
- 46 patients will benefit from the program,
- 23 patients will form the control group.
- 6 patients will not answer to all the criteria.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicentric, controlled, national study
| Arm | Type | Receives |
|---|---|---|
| FabLife group | Experimental | Device: FabLifeFablife personnalised support and telephone follow-up with a dietician. |
| Control group | No intervention | –General dietary recommendations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary infertility greater than 12 months
- Conventional spermatic parameters compatible with spontaneous pregnancy
- Negative spermoculture
- Fragmentation of sperm DNA> 20%
- Patient able to understand dietary recommendations given in French, in writing and orally
Key exclusion criteria (14 listed)
- Patient diagnosed with severe oligospermia (<5 million spz / ejaculate)
- Patient with BMI> 35 or <18.5
- Patient with known and treated diabetes
- Patient with known and treated lipid disorders
- Patient with known and treated cardiovascular diseases
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 |
|---|---|---|
| FabLife* A personnalized dietary program depending on the patient's phenotype and genotype * The daily intake of a dietary supplement, developped in the context of male infertility. | Device | FabLife group |
Primary outcome
Sperm DNA fragmentation
Time frame: 15 weeks
Difference in sperm DNA fragmentation from baseline to post-treatment
6 secondary outcomes
Semen quality
Time frame: 15 weeks
Sperm motility
Time frame: 15 weeks
Sperm morphology
Time frame: 15 weeks
Sperm concentration
Time frame: 15 weeks
Semen volume
Time frame: 15 weeks
Total sperm count
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Rachel Levy, Md, PhD, Pr principal investigator
Hopital Tenon (AP-HP) France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FabLife in people with Male Infertility, run by FabLife at 2 sites in France.
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 9 inclusion and 14 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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 Eric M Lameignere, PhD (+ 33 784 29 59 71, e.lameignere@fablife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm DNA fragmentation (time frame: 15 weeks). 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 15 Feb 2019; AzTrials last refreshed its copy on 28 Oct 2026.