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The Effect of a Multimodal Lifestyle Program on Male Fertility

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ClinicalTrials.gov Identifier: NCT04761250
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

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


Condition or disease Intervention/treatment Phase
Infertility, Male Dietary Supplement: Lifestyle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022


Arm Intervention/treatment
Experimental: Intervention
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Dietary Supplement: Lifestyle
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation




Primary Outcome Measures :
  1. Increase in the total amount of motil sperm in male patients undergoing fertility treatment [ Time Frame: 90 days ]
    Change in classical sperm parameters


Secondary Outcome Measures :
  1. Change in DNA fragmentation index (DFI) [ Time Frame: 90 days ]
    DFI is measured by Comet Assay

  2. Changes in parameters for metabolic syndrome [ Time Frame: 90 days ]
    Weight in kilograms

  3. Changes in parameters for metabolic syndrome [ Time Frame: 90 days ]
    BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2

  4. Changes in parameters for metabolic syndrome [ Time Frame: 90 days ]
    Blood pressure in millimeters of mercury

  5. Change in plasma lipids [ Time Frame: 90 days ]
    Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761250


Locations
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Denmark
Fertility Clinic Skive, Skive Regional Hospital Recruiting
Skive, Denmark, 7800
Contact: Peter Humaidan, DMSc    +4578445760    fertilitetsklinikken@midt.rm.dk   
Sponsors and Collaborators
Peter Humaidan
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Responsible Party: Peter Humaidan, Professor, Consultant, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT04761250    
Other Study ID Numbers: 1-10-72-109-20
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Humaidan, Regionshospitalet Viborg, Skive:
Male infertility
Semen quality
Lifestyle intervention
Additional relevant MeSH terms:
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Infertility
Infertility, Male