Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

NCT ID: NCT03898752

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oligospermia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle intervention

Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise,

Group Type EXPERIMENTAL

Omega 3

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Coenzyme Q10 (CoQ10) Multi-vitamin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Genetic diseases
* Azospermia
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Peter Humaidan

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Professor, MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Fertility Clinic Skive

Skive, Central Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34472769 (View on PubMed)

Other Identifiers

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MiOxysis_Skive

Identifier Type: -

Identifier Source: org_study_id

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