Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

Male Infertility Clinical Trial

— FabLife  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475199
• Other study ID #: 2017-AO3218-45
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: FabLife
• Contact: Eric M Lameignere, PhD
• Phone: + 33 784 29 59 71
• Email: e.lameignere[@]fablife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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.

Locations

Country	Name	City	State
France	Drouot Laboratory	Paris
France	Tenon Hospital (AP-HP)	Paris

Sponsors (2)

Lead Sponsor	Collaborator
FabLife	Keyrus Biopharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm DNA fragmentation	Difference in sperm DNA fragmentation from baseline to post-treatment	15 weeks
Secondary	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
Secondary	Sperm motility	Difference in sperm motility from baseline to post-treatment.	15 weeks
Secondary	Sperm morphology	Difference in sperm morphology from baseline to post-treatment.	15 weeks
Secondary	Sperm concentration	Difference in sperm concentration from baseline to post-treatment.	15 weeks
Secondary	Semen volume	Difference in semen volume from baseline to post-treatment.	15 weeks
Secondary	Total sperm count	Difference in total sperm count from baseline to post-treatment.	15 weeks