Evaluation of Personalised Support Program Effectiveness... | NCT03475199

Studies
Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement

NCT03475199

Sponsor

FabLife

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Male Infertility

Interventions

FabLife

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Name	Class
Keyrus Biopharma	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FabLife group	Experimental	Fablife personnalised support and telephone follow-up with a dietician.	Device: FabLife
Control group	No Intervention	General dietary recommendations.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FabLife	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sperm DNA fragmentation	Difference in sperm DNA fragmentation from baseline to post-treatment	15 weeks

Secondary Outcomes

Measure	Description	Time Frame
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
Sperm motility

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility