Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 2:34 AM
Study NCT ID:
NCT04589793
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COaching Lifestyle Intervention for FErtility
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
COaching Lifestyle Intervention for FErtility
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLIFE
Brief Summary:
In Finland, every third woman is overweight (BMI\>25) and 11,5% obese (BMI\>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: