Oxidative Stress In Semen And Male Infertility

Summary

The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants.

After completing the data analysis, we intend to publish the study in high impact perr reviewed journals and present it in international conferences.

Conditions

• Antioxidants
• Infertility, Male
• Semen Quality

Interventions

DRUG

Fairhaven Pro for men

Fairhaven Pro for men The antioxidant formula (Fairhaven Health) contains: * B12 (1000 mcg) * Zinc (30 mg) * Selenium (140 mcg) * Arginine (350 mg) * L-carnitine tartrate (2000 mg) , providing 1,340 mg of L-carnitine * CoQ10 (200 mg) * Vitamin C (120 mg) and Vitamin E (200 IU)

DIAGNOSTIC_TEST

Semen analysis

Full semen analysis according to WHO semen laboratory manual 5th edition will be done pre and 3 months post-treatment. After complete liquefaction, each sample was evaluated for both macroscopic parameters such as color, pH, ejaculate volume, age of the sample and viscosity. An aliquot of the sample was examined for sperm concentration, total sperm count, total and progressive motility and sperm morphology using the WHO fifth edition guidelines (WHO, 2010). Semen analysis was done manually using a hemocytometer. Sperm motility was assessed and categorized as progressive or non-progressive. Morphology was assessed by a single experienced technician using the Diff-Quik staining protocol. Kruger's strict criteria were used for morphology assessment with 4% normal morphology as a cut-off (WHO, 2010).

DIAGNOSTIC_TEST

Sperm DNA fragmentation

Sperm DNA fragmentation was evaluated using the Halosperm kit from Halotech DNA, S.L. (Madrid, Spain) as per manufacturer instructions. The method is based on the sperm chromatin dispersion test (Fernández et al., 2003). A minimum of 500 spermatozoa were scored and reported as percentage of sperm with spermatozoa with fragmented DNA. Normal value is measure at a cut-off value of more than 30%

DIAGNOSTIC_TEST

Static Oxidation reduction potential in semen

Oxidative stress was assessed by measuring the static oxidation-reduction potential (sORP) of neat liquefied semen samples using the MiOXSYSTM System (Aytu Bioscience, Inc., Englewood, USA). This is a galvanostatic measure of the electron transfer from reductants (antioxidants) to oxidants under a steady low voltage reducing current. Thus, providing an aggregate measure of all current oxidant activity and antioxidant activity in a sample. Higher sORP values (millivolts, mV) indicate a higher oxidant activity relative to the antioxidant activity and therefore greater state of oxidative stress.

Sponsors & Collaborators

• Fairhaven Health

  collaborator INDUSTRY

• Hamad Medical Corporation

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2018-07-01

Completion

2018-12-01

Countries

• Qatar

Study Locations