Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement (FabLife)

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.

Study Overview

• Status: Unknown
• Conditions: Male Infertility
• Intervention / Treatment: Device: FabLife

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric M Lameignere, PhD; Phone Number: + 33 784 29 59 71; Email: e.lameignere@fablife.com

Study Locations

• France
  • Paris, France, 75009
    • Recruiting
    • Drouot Laboratory
    • Contact: Cassuto Guy, Dr
    • Principal Investigator: Dominique MAUGET-BOURET, Dr
  • Paris, France, 75019
    • Not yet recruiting
    • Tenon Hospital (AP-HP)
    • Contact: Rachel LEVY; Phone Number: +331 56 01 70 02; Email: rachel.levy@aphp.fr
    • Principal Investigator: Rachel LEVY, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: FabLife
• Collaborators: Keyrus Biopharma
• Investigators: Principal Investigator: Rachel Levy, Md, PhD, Pr, Hopital Tenon (AP-HP) France

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: 2017-AO3218-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No