Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

Not Applicable

• Conditions: Male Infertility
• Interventions: Device: FabLife

• Registration Number: NCT03475199
• Lead Sponsor: FabLife

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.

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FabLife group	FabLife	Fablife personnalised support and telephone follow-up with a dietician.

Primary Outcome Measures

Name	Time	Method
Sperm DNA fragmentation	15 weeks	Difference in sperm DNA fragmentation from baseline to post-treatment

Secondary Outcome Measures

Name	Time	Method
Sperm motility	15 weeks	Difference in sperm motility 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.
Sperm morphology	15 weeks	Difference in sperm morphology from baseline to post-treatment.
Total sperm count	15 weeks	Difference in total sperm count from baseline to post-treatment.
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.

Trial Locations

Locations (2)

Tenon Hospital (AP-HP); 🇫🇷 Paris, France

Drouot Laboratory; 🇫🇷 Paris, France