Status:
UNKNOWN
Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement
Lead Sponsor:
FabLife
Collaborating Sponsors:
Keyrus Biopharma
Conditions:
Male Infertility
Eligibility:
MALE
18-45 years
Phase:
NA
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 ...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03475199
Start Date
February 13 2018
End Date
December 1 2019
Last Update
February 15 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Drouot Laboratory
Paris, France, 75009
2
Tenon Hospital (AP-HP)
Paris, France, 75019