The Effect of a Multimodal Lifestyle Program on Male Fertility

Not Applicable

Completed

• Conditions: Infertility, Male
• Interventions: Dietary Supplement: Lifestyle

• Registration Number: NCT04761250
• Lead Sponsor: Peter Humaidan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study Start: 2021-02-15
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Primary Completion: 2022-06-01
• Status Verified: 2022-09
• Study Completion: 2022-09-12
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Lifestyle	Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Primary Outcome Measures

Name	Time	Method
Increase in the total amount of motil sperm in male patients undergoing fertility treatment	90 days	Change in classical sperm parameters

Secondary Outcome Measures

Name	Time	Method
Change in DNA fragmentation index (DFI)	90 days	DFI is measured by Comet Assay
Change in plasma lipids	90 days	Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Changes in parameters for metabolic syndrome	90 days	Blood pressure in millimeters of mercury

Trial Locations

Locations (1)

Fertility Clinic Skive, Skive Regional Hospital; 🇩🇰 Skive, Denmark