Impact of Antioxidant Treatment on DNA Fragmentation Index

NCT03466229 | Completed

• 1 other identifier: Androferti
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

Increased sperm DNA Fragmentation Index implies decreased male fertility in vivo and in vitro. There is need for developing new strategies for improvement of male fertility. The study aims to investigate whether high sperm DNA Integration Index can be treated by use of antioxidants.

Conditions

Male Infertility

Keywords

sperm DNA strand breaks; antioxidants

Outcome Measures

Primary Outcomes (2)

• DFI_3

  3\_month\_change\_DNA Fragmentation Index assessed by Sperm Chromatin

  Change in DNA Fragmentation Index from Baseline to 3 months

• DFI_6

  6\_month\_change\_DNA Fragmentation Index assessed by Sperm Chromatin Structure Assay

  Change in DNA Fragmentation Index from Baseline to 6 months

Secondary Outcomes (6)

• Concentration_3

  Change in sperm concentration from baseline to 3 months in millions/mL

• Concentration_6

  Change in sperm concentration from baseline to 6 months in millions/mL

• Motility_3

  Change in sperm motility from baseline to 3 months in %

• Motility_6

  Change in sperm motility from baseline to 6 months in %

• Morphology_3

  Change in sperm morphology from baseline to 3 months in %

Study Arms (2)

Antioxidant

ACTIVE COMPARATOR

Androferti - 1 twice per day

Dietary Supplement: Androferti

Placebo

PLACEBO COMPARATOR

Placebo - 1 twice per day

Dietary Supplement: Placebo

Interventions

Androferti DIETARY_SUPPLEMENT

Antioxidant

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Men able to deliver semen sample and investigated due to infertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Referred due to infertility
• Age: 18-50 years,
• Non-smoking,
• Sperm DNA Fragmentation Index \>25%

You may not qualify if:

• Body mass index (BMI) ≥30,
• FSH outside the normal range of 2-8 IU/L,g)
• LH outside the normal range of 2-10 IU/L,
• T \< 10nmol/L
• Treated with antihypertensive drugs, hormones, statins, psychotropic drugs, or oral cortisone for the last six months,
• History of anabolic steroids use,
• Taking antioxidant supplementation the last six months.

Sponsors & Collaborators

• Region Skane: lead
• Q-Pharma: collaborator
• Octean: collaborator

Related Publications (1)

• Stenqvist A, Oleszczuk K, Leijonhufvud I, Giwercman A. Impact of antioxidant treatment on DNA fragmentation index: a double-blind placebo-controlled randomized trial. Andrology. 2018 Nov;6(6):811-816. doi: 10.1111/andr.12547. Epub 2018 Oct 8.

  PMID: 30298673 DERIVED

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The active compound and placebo are given a number and the list linking this number to the type of preparation (placebo or active compound) is stored by one of the sponsors (Octean)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blind randomised placebo controlled study

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 15, 2018
• Study Start: July 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: March 16, 2018

Record last verified: 2018-03