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

FabLife

Status

Unknown

Conditions

Male Infertility

Treatments

Device: FabLife

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03475199

2017-AO3218-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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