An interventional study of Omega 3 in Oligospermia, sponsored by Peter Humaidan. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Peter Humaidan · Not applicable, Interventional, and Prevention
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 31 is below the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Peter Humaidan is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
Also known as: Coenzyme Q10 (CoQ10), Multi-vitamin
Oxidative stress
Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).
Time frame: 3 months
Semen quality
Morphological semen parameters using WHO recommendation for semen analysis.
Time frame: 3 months
DNA fragmentation index
DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)
Time frame: 3 months
Plan to share: Undecided — Not allowed by Danish legislation to publish individual meta-data.
Ran from Nov 2018 to primary completion in May 2020, 18 months.
Of 16 interventional studies with no phase under Oligospermia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 36. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Peter Humaidan