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Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03898752
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : February 19, 2020
The Cleveland Clinic
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Oligospermia Dietary Supplement: Omega 3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All men with DFI >15 (SCSA method) are assigned to life-style intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle intervention
Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise,
Dietary Supplement: Omega 3
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 Outcome Measures :
  1. Oxidative stress [ Time Frame: 3 months ]
    Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).

Secondary Outcome Measures :
  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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MiOxysis above 1.34
  • Attending IVF treatment for unknown or male factor infertility.

Exclusion Criteria:

  • Genetic diseases
  • Azospermia

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 identifier (NCT number): NCT03898752

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Contact: Peter Humaidan, MD 78 44 57 60 ext +45

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The Fertility Clinic Skive Recruiting
Skive, Central Denmark Region, Denmark, 7800
Contact: Peter Humaidan, MD         
Sponsors and Collaborators
Peter Humaidan
The Cleveland Clinic
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Responsible Party: Peter Humaidan, Professor, MD, Regionshospitalet Viborg, Skive Identifier: NCT03898752    
Other Study ID Numbers: MiOxysis_Skive
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not allowed by Danish legislation to publish individual meta-data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility, Male
Genital Diseases, Male
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs