Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

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.

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.

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