Male Infertility
Conditions
Brief 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.
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.
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.
Sponsors
Keyrus Biopharma
FabLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Prospective, multicentric, controlled, national study
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm DNA fragmentation | 15 weeks | Difference in sperm DNA fragmentation from baseline to post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semen quality | 15 weeks | Difference in semen quality (semen variables including total sperm count, sperm concentration, sperm motility, sperm morphology and semen volume) from baseline to post-treatment. |
| Sperm motility | 15 weeks | Difference in sperm motility from baseline to post-treatment. |
| Sperm morphology | 15 weeks | Difference in sperm morphology from baseline to post-treatment. |
| Sperm concentration | 15 weeks | Difference in sperm concentration from baseline to post-treatment. |
| Semen volume | 15 weeks | Difference in semen volume from baseline to post-treatment. |
| Total sperm count | 15 weeks | Difference in total sperm count from baseline to post-treatment. |
Countries
France
Contacts
Primary ContactEric M Lameignere, PhD
Outcome results
None listed