Skip to content

Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03898752
Enrollment
31
Registered
2019-04-02
Start date
2018-11-01
Completion date
2020-11-01
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligospermia

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.

Interventions

DIETARY_SUPPLEMENTOmega 3

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

Sponsors

Peter Humaidan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All men with DFI \>15 (SCSA method) are assigned to life-style intervention.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Genetic diseases * Azospermia

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress3 monthsOxidative stress as measured with MiOxysis (Ayto Bioscience inc).

Secondary

MeasureTime frameDescription
Semen quality3 monthsMorphological semen parameters using WHO recommendation for semen analysis.
DNA fragmentation index3 monthsDNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026