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OpenTrials
Completed

NCT Number: NCT03898752

Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

In this study we aim to investigate whether a 3-month life-style intervention would reduce oxidative stress (OS) in semen in men of infertile couples attending IVF-treatment. Men with a DFI above 15% (SCSA method) are recruited for intervention with a 3-month follow-up.

It is hypothesized that men who also have a OS above 1.34 using a novel OS diagnostic method (MiOXSYS) respond better to antioxidant treatment with a change in OS and DFI. The primary outcome is the change in OS following the intervention. Secondary outcomes are morphological semen parameters and DNA fragmentation index.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Fertility Clinic Skive

Skive, Central Jutland, 7800, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DFI>15
  • Attending IVF treatment for unknown or male factor infertility.

Exclusion criteria

  • Genetic diseases
  • Azospermia

Treatment and study plan

Omega 3

Dietary Supplement

Omega 3: 1g daily for 3 months CoQ10: 100 mg daily for 3 months Multivitamin: 1 normal multivitamin tablet daily for 3 months

Other names: Coenzyme Q10 (CoQ10), Multi-vitamin

Primary outcomes

  1. Oxidative stress

    Time frame: 3 months

    Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).

Secondary outcomes

  1. Semen quality

    Time frame: 3 months

    Morphological semen parameters using WHO recommendation for semen analysis.

  2. DNA fragmentation index

    Time frame: 3 months

    DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2019
Registry last updated
Mar 22, 2021

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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