Back to resultsIs Oxidative Stress in Semen Reduced by Lifestyle Intervention
Primary Purpose
Oligospermia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Omega 3
Sponsored by
About this trial
This is an interventional prevention trial for Oligospermia
Eligibility Criteria
Inclusion Criteria:
- DFI>15
- Attending IVF treatment for unknown or male factor infertility.
Exclusion Criteria:
- Genetic diseases
- Azospermia
Sites / Locations
- The Fertility Clinic Skive
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle intervention
Arm Description
Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise,
Outcomes
Primary Outcome Measures
Oxidative stress
Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).
Secondary Outcome Measures
Semen quality
Morphological semen parameters using WHO recommendation for semen analysis.
DNA fragmentation index
DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03898752
Brief Title
Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
Official Title
Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Humaidan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligospermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All men with DFI >15 (SCSA method) are assigned to life-style intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise,
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3
Other Intervention Name(s)
Coenzyme Q10 (CoQ10), Multi-vitamin
Intervention Description
Omega 3: 1g daily for 3 months CoQ10: 100 mg daily for 3 months Multivitamin: 1 normal multivitamin tablet daily for 3 months
Primary Outcome Measure Information:
Title
Oxidative stress
Description
Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Semen quality
Description
Morphological semen parameters using WHO recommendation for semen analysis.
Time Frame
3 months
Title
DNA fragmentation index
Description
DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DFI>15
Attending IVF treatment for unknown or male factor infertility.
Exclusion Criteria:
Genetic diseases
Azospermia
Facility Information:
Facility Name
The Fertility Clinic Skive
City
Skive
State/Province
Central Denmark Region
ZIP/Postal Code
7800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not allowed by Danish legislation to publish individual meta-data.
Citations:
PubMed Identifier
34472769
Citation
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.
Results Reference
derived
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Is Oxidative Stress in Semen Reduced by Lifestyle Intervention
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