The Effect of a Multimodal Lifestyle Program on Male Fertility

Infertility, Male Clinical Trial

Official title:

Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761250
• Other study ID #: 1-10-72-109-20
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: September 12, 2022

Study information

• Verified date: September 2022
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 12, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Dietary Supplement:
• Lifestyle
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Locations

Country	Name	City	State
Denmark	Fertility Clinic Skive, Skive Regional Hospital	Skive

Sponsors (1)

Lead Sponsor	Collaborator
Peter Humaidan

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in the total amount of motil sperm in male patients undergoing fertility treatment	Change in classical sperm parameters	90 days
Secondary	Change in DNA fragmentation index (DFI)	DFI is measured by Comet Assay	90 days
Secondary	Changes in parameters for metabolic syndrome	Weight in kilograms	90 days
Secondary	Changes in parameters for metabolic syndrome	BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2	90 days
Secondary	Changes in parameters for metabolic syndrome	Blood pressure in millimeters of mercury	90 days
Secondary	Change in plasma lipids	Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides	90 days