Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

NCT03475199 | Unknown

• 1 other identifier: 2017-AO3218-45
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• Sperm DNA fragmentation

  Difference in sperm DNA fragmentation from baseline to post-treatment

  15 weeks

Secondary Outcomes (6)

• Semen quality

  15 weeks

• Sperm motility

  15 weeks

• Sperm morphology

  15 weeks

• Sperm concentration

  15 weeks

• Semen volume

  15 weeks

Study Arms (2)

FabLife group

EXPERIMENTAL

Fablife personnalised support and telephone follow-up with a dietician.

Device: FabLife

Control group

NO INTERVENTION

General dietary recommendations.

Interventions

FabLife DEVICE

* 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.

FabLife group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FabLife: lead
• Keyrus Biopharma: collaborator

Study Sites (2)

Drouot Laboratory

Paris, 75009, France

RECRUITING

Tenon Hospital (AP-HP)

Paris, 75019, France

NOT YET RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Rachel Levy, Md, PhD, Pr

  Hopital Tenon (AP-HP) France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M Lameignere, PhD

CONTACT

+ 33 784 29 59 71; e.lameignere@fablife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, controlled, national study

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 23, 2018
• Study Start: February 13, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

FR (2)