The Effect of a Multimodal Lifestyle Program on Male Fertility

September 26, 2022 updated by: Peter Humaidan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Skive, Denmark, 7800
        • Fertility Clinic Skive, Skive Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in the total amount of motil sperm in male patients undergoing fertility treatment
Time Frame: 90 days
Change in classical sperm parameters
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Humaidan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2021

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

September 12, 2022

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (ACTUAL)

February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-109-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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