Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility

Conditions
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Male Infertility

Intervention / Treatment
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* Device: FabLife


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicentric, controlled, national study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FabLife group<br>Fablife personnalised support and telephone follow-up with a dietician. | Device: FabLife<br>* 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.<br>|
| No Intervention: Control group<br>General dietary recommendations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA fragmentation | Difference in sperm DNA fragmentation from baseline to post-treatment | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 weeks | 
| Sperm motility | Difference in sperm motility from baseline to post-treatment. | 15 weeks | 
| Sperm morphology | Difference in sperm morphology from baseline to post-treatment. | 15 weeks | 
| Sperm concentration | Difference in sperm concentration from baseline to post-treatment. | 15 weeks | 
| Semen volume | Difference in semen volume from baseline to post-treatment. | 15 weeks | 
| Total sperm count | Difference in total sperm count from baseline to post-treatment. | 15 weeks |