Is Oxidative Stress in Semen Reduced by Lifestyle Intervention

NCT03898752 — Not applicable, Completed, 31 participants, Peter Humaidan

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Registry	NCT03898752
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	31 (Actual)
Sponsor	Peter Humaidan (Other)
Conditions	Oligospermia
Interventions	Omega 3 (Dietary supplement)
Dates	start 2018-11-01, primary completion 2020-05-01, completion 2020-11-01, first posted 2019-04-02, last updated 2021-03-22
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lifestyle intervention	Experimental	Dietary Supplement: Omega 3	Diet, omega-3 fish oil (1g daily), CoQ10 (100 mg/day) and a normal Multi-vitamin, Smoking cessation, weight loss, exercise,

Omega 3 (Dietary supplement), also known as Coenzyme Q10 (CoQ10), Multi-vitamin: Omega 3: 1g daily for 3 months CoQ10: 100 mg daily for 3 months Multivitamin: 1 normal multivitamin tablet daily for 3 months

+Outcome measures

Primary outcomes

Oxidative stress [3 months]: Oxidative stress as measured with MiOxysis (Ayto Bioscience inc).

Secondary outcomes

Semen quality [3 months]: Morphological semen parameters using WHO recommendation for semen analysis.
DNA fragmentation index [3 months]: DNA fragmentation index as measured by the method by SPZlab A/S (SCSA method)

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Genetic diseases
* Azospermia

+Locations (1)

Facility	City	Country	Status
The Fertility Clinic Skive	Skive, Central Jutland	Denmark

+Publications

Results publication: 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