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OpenTrials
Completed

NCT Number: NCT04761250

The Effect of a Multimodal Lifestyle Program on Male Fertility

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

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Clinic Skive, Skive Regional Hospital

Skive, 7800, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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