Clinical trial NCT03475199: Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement
Official title: Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Lead sponsor: FabLife
Sponsor class: INDUSTRY
Collaborators: name: Keyrus Biopharma
First posted: 2018-03-23
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicentric, controlled, national study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sperm DNA fragmentation
timeFrame: 15 weeks
Secondary outcomes:
measure: Semen quality
timeFrame: 15 weeks
measure: Sperm motility
timeFrame: 15 weeks
measure: Sperm morphology
timeFrame: 15 weeks
measure: Sperm concentration
timeFrame: 15 weeks
measure: Semen volume
timeFrame: 15 weeks
measure: Total sperm count
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Drouot Laboratory
city: Paris
country: France
facility: Tenon Hospital (AP-HP)
Study officials:
affiliation: Hopital Tenon (AP-HP) France
name: Rachel Levy, Md, PhD, Pr
role: PRINCIPAL_INVESTIGATOR
References: