Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

NCT03898752 | Completed

• 1 other identifier: MiOxysis_Skive
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Oligospermia

Outcome Measures

Primary Outcomes (1)

• Oxidative stress

  Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).

  3 months

Secondary Outcomes (2)

• Semen quality

  3 months

• DNA fragmentation index

  3 months

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

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

Interventions

Omega 3 DIETARY_SUPPLEMENT

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

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Genetic diseases
• Azospermia

Sponsors & Collaborators

• Peter Humaidan: lead

Study Sites (1)

The Fertility Clinic Skive

Skive, Central Jutland, 7800, Denmark

Location

Related Publications (1)

• Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604.

  PMID: 34472769 DERIVED

MeSH Terms

Conditions

Oligospermia

Interventions

Docosahexaenoic Acids; coenzyme Q10; Geritol

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

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

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: November 1, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

DK (1)