Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Oligospermia Clinical Trial

Official title:

Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898752
• Other study ID #: MiOxysis_Skive
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: March 2021
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• DFI>15

• Attending IVF treatment for unknown or male factor infertility.

Exclusion Criteria:

• Genetic diseases

• Azospermia

Related Conditions & MeSH terms

• Oligospermia

Intervention

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

Locations

Country	Name	City	State
Denmark	The Fertility Clinic Skive	Skive	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Peter Humaidan

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress	Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).	3 months
Secondary	Semen quality	Morphological semen parameters using WHO recommendation for semen analysis.	3 months
Secondary	DNA fragmentation index	DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)	3 months