ClinicalTrials.gg
Status unknownNCT03475199FabLifeUpdated Feb 15, 2019

Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

An interventional study of FabLife in Male Infertility, sponsored by FabLife. Status unknown at 2 sites in France. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by FabLife · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Infertility, Male with a site in France — 2 open to participants now, 2 under way, none of them phase 3. Infertility, Male · France.

Started
2018
with 1 other
No phase
6 of 11
1 open now
Registered
7th of 11
by date
Lead sponsor
1 of 11
FabLife

Among the 11 studies in Infertility, Male with a site in France, this one is one of 2 that started in 2018, is one of 6 with no phase, and was the 7th registered.

Infertility, Male

282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.

Browse Infertility, Male studies →

Open to participants now

2 of the 11 studies in Infertility, Male with a site in France are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 45 Years · male · no healthy volunteers.

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02

Study 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 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.
03

Conditions studied

  • Male Infertility

Browse trials for

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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%
  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient diagnosed with severe oligospermia (\<5 million spz / ejaculate)
  • Patient with > 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
  • 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 ( / and C / ...) requiring support in a dedicated circuit
  • Patient unable to give
  • Minors and protected adults, vulnerable people
  • Patient participating in another clinical research study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    FabLife group

    Fablife personnalised support and telephone follow-up with a dietician.

    Device: FabLife

  • No intervention
    Control group

    General dietary recommendations.

Interventions

  • DeviceFabLife

    * 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.

06

What researchers measure

Primary outcomes

  1. Sperm DNA fragmentation

    Difference in sperm DNA fragmentation from baseline to post-treatment

    Time frame: 15 weeks

Secondary outcomes

  1. 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.

    Time frame: 15 weeks

  2. Sperm motility

    Difference in sperm motility from baseline to post-treatment.

    Time frame: 15 weeks

  3. Sperm morphology

    Difference in sperm morphology from baseline to post-treatment.

    Time frame: 15 weeks

  4. Sperm concentration

    Difference in sperm concentration from baseline to post-treatment.

    Time frame: 15 weeks

  5. Semen volume

    Difference in semen volume from baseline to post-treatment.

    Time frame: 15 weeks

  6. Total sperm count

    Difference in total sperm count from baseline to post-treatment.

    Time frame: 15 weeks

07

Study locations

1 of 2 sites recruiting
  • Drouot Laboratory
    Paris, 75009, France
    Recruiting
    • Cassuto Guy, Dr · Contact
    • Dominique MAUGET-BOURET, Dr · Principal investigator
  • Tenon Hospital (AP-HP)
    Paris, 75019, France
    Not yet recruiting
    • Rachel LEVY · Contactrachel.levy@aphp.fr · +331 56 01 70 02
    • Rachel LEVY, Pr · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Jun 2019, 16 months after the start.

Of 92 interventional studies with no phase under Infertility, Male, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 23, 2018
StartActual
Feb 13, 2018
Primary completionEst.
Jun 2019
CompletionEst.
Dec 2019
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03475199
Lead sponsor
FabLife
Collaborators
Keyrus Biopharma
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Feb 13, 2018
Primary completion
Jun 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Eric M Lameignere, PhD
Contact
e.lameignere@fablife.com
+ 33 784 29 59 71
Rachel Levy, Md, PhD, Pr
principal investigator · Hopital Tenon (AP-HP) France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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