Back to resultsThe Effect of a Multimodal Lifestyle Program on Male Fertility
Primary Purpose
Infertility, Male
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male focused on measuring Male infertility, Semen quality, Lifestyle intervention
Eligibility Criteria
Inclusion Criteria:
- Men of couples who are about to start 2nd or 3rd fertility treatment
- > 18 years old
- Sperm concentration between 2-40 mill./ml
Exclusion Criteria:
- Use of testicular sperm
Sites / Locations
- Fertility Clinic Skive, Skive Regional Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Outcomes
Primary Outcome Measures
Increase in the total amount of motil sperm in male patients undergoing fertility treatment
Change in classical sperm parameters
Secondary Outcome Measures
Change in DNA fragmentation index (DFI)
DFI is measured by Comet Assay
Changes in parameters for metabolic syndrome
Weight in kilograms
Changes in parameters for metabolic syndrome
BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2
Changes in parameters for metabolic syndrome
Blood pressure in millimeters of mercury
Change in plasma lipids
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04761250
Brief Title
The Effect of a Multimodal Lifestyle Program on Male Fertility
Official Title
Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Humaidan
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
A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.
The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Male infertility, Semen quality, Lifestyle intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Lifestyle
Intervention Description
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Primary Outcome Measure Information:
Title
Increase in the total amount of motil sperm in male patients undergoing fertility treatment
Description
Change in classical sperm parameters
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in DNA fragmentation index (DFI)
Description
DFI is measured by Comet Assay
Time Frame
90 days
Title
Changes in parameters for metabolic syndrome
Description
Weight in kilograms
Time Frame
90 days
Title
Changes in parameters for metabolic syndrome
Description
BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2
Time Frame
90 days
Title
Changes in parameters for metabolic syndrome
Description
Blood pressure in millimeters of mercury
Time Frame
90 days
Title
Change in plasma lipids
Description
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Time Frame
90 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men of couples who are about to start 2nd or 3rd fertility treatment
> 18 years old
Sperm concentration between 2-40 mill./ml
Exclusion Criteria:
Use of testicular sperm
Facility Information:
Facility Name
Fertility Clinic Skive, Skive Regional Hospital
City
Skive
ZIP/Postal Code
7800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Multimodal Lifestyle Program on Male Fertility
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