search
Back to results

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

Primary Purpose

Male Infertility

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FabLife
Sponsored by
FabLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Male Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Drouot LaboratoryRecruiting
  • Tenon Hospital (AP-HP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FabLife group

Control group

Arm Description

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

General dietary recommendations.

Outcomes

Primary Outcome Measures

Sperm DNA fragmentation
Difference in sperm DNA fragmentation from baseline to post-treatment

Secondary Outcome Measures

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.
Sperm motility
Difference in sperm motility from baseline to post-treatment.
Sperm morphology
Difference in sperm morphology from baseline to post-treatment.
Sperm concentration
Difference in sperm concentration from baseline to post-treatment.
Semen volume
Difference in semen volume from baseline to post-treatment.
Total sperm count
Difference in total sperm count from baseline to post-treatment.

Full Information

First Posted
March 12, 2018
Last Updated
February 12, 2019
Sponsor
FabLife
Collaborators
Keyrus Biopharma
search

1. Study Identification

Unique Protocol Identification Number
NCT03475199
Brief Title
Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement
Acronym
FabLife
Official Title
Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FabLife
Collaborators
Keyrus Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicentric, controlled, national study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FabLife group
Arm Type
Experimental
Arm Description
Fablife personnalised support and telephone follow-up with a dietician.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
General dietary recommendations.
Intervention Type
Device
Intervention Name(s)
FabLife
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sperm DNA fragmentation
Description
Difference in sperm DNA fragmentation from baseline to post-treatment
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Semen quality
Description
Difference in semen quality (semen variables including total sperm count, sperm concentration, sperm motility, sperm morphology and semen volume) from baseline to post-treatment.
Time Frame
15 weeks
Title
Sperm motility
Description
Difference in sperm motility from baseline to post-treatment.
Time Frame
15 weeks
Title
Sperm morphology
Description
Difference in sperm morphology from baseline to post-treatment.
Time Frame
15 weeks
Title
Sperm concentration
Description
Difference in sperm concentration from baseline to post-treatment.
Time Frame
15 weeks
Title
Semen volume
Description
Difference in semen volume from baseline to post-treatment.
Time Frame
15 weeks
Title
Total sperm count
Description
Difference in total sperm count from baseline to post-treatment.
Time Frame
15 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric M Lameignere, PhD
Phone
+ 33 784 29 59 71
Email
e.lameignere@fablife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Levy, Md, PhD, Pr
Organizational Affiliation
Hopital Tenon (AP-HP) France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drouot Laboratory
City
Paris
ZIP/Postal Code
75009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassuto Guy, Dr
First Name & Middle Initial & Last Name & Degree
Dominique MAUGET-BOURET, Dr
Facility Name
Tenon Hospital (AP-HP)
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel LEVY
Phone
+331 56 01 70 02
Email
rachel.levy@aphp.fr
First Name & Middle Initial & Last Name & Degree
Rachel LEVY, Pr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

We'll reach out to this number within 24 hrs