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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention | Experimental | Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress | Oxidative stress as measured with MiOxysis (Ayto Bioscience inc). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Semen quality | Morphological semen parameters using WHO recommendation for semen analysis. | 3 months |
| DNA fragmentation index | DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fertility Clinic Skive | Skive | Central Jutland | 7800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34472769 | Derived | 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. |
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Not allowed by Danish legislation to publish individual meta-data.
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| ID | Term |
|---|---|
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| C024989 | coenzyme Q10 |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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All men with DFI >15 (SCSA method) are assigned to life-style intervention.
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|
| 3 months |
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |