Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
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|ClinicalTrials.gov Identifier: NCT03898752|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : February 19, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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
- Oxidative stress [ Time Frame: 3 months ]Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).
- Semen quality [ Time Frame: 3 months ]Morphological semen parameters using WHO recommendation for semen analysis.
- DNA fragmentation index [ Time Frame: 3 months ]DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898752
|Contact: Peter Humaidan, MD||78 44 57 60 ext +firstname.lastname@example.org|
|The Fertility Clinic Skive||Recruiting|
|Skive, Central Denmark Region, Denmark, 7800|
|Contact: Peter Humaidan, MD|