Oxidative Stress In Semen And Male Infertility

NCT03464656 | Unknown Phase 4 DMC

• 1 other identifier: 16351/16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

semen; male infertility; semen quality; sperm DNA fragmentation; oxidation reduction potential

Outcome Measures

Primary Outcomes (3)

• Evaluate the effect of antioxidant therapy on sperm motility in infertile men,

  Measured by mean change in sperm motility pre- and post-treatment with antioxidants.

  1 year

• Evaluate the effect of antioxidant therapy on sperm morphology in infertile men

  Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants

  1 year

• Evaluate the effect of antioxidant therapy on sperm count in infertile men

  Measured by mean change in sperm count pre- and post-treatment with antioxidants.

  1 year

Secondary Outcomes (2)

• Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men

  1 year

• Evaluate the effect of antioxidant therapy on oxidative stress in infertile men

  1 year

Study Arms (1)

Patients

EXPERIMENTAL

Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. Interventions: * Patients will be given Fairhaven Pro for Men as antioxidant in a dose of 3 tablets twice daily for 3 months. * Full assessment of fertility will be done.

Drug: Fairhaven Pro for men; Diagnostic Test: Semen analysis; Diagnostic Test: Sperm DNA fragmentation; Diagnostic Test: Static Oxidation reduction potential in semen

Interventions

Fairhaven Pro for men DRUG

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)

Also known as: Antioxidant

Patients

Semen analysis DIAGNOSTIC_TEST

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).

Also known as: Semen test

Patients

Sperm DNA fragmentation DIAGNOSTIC_TEST

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%

Also known as: SDF

Patients

Static Oxidation reduction potential in semen DIAGNOSTIC_TEST

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.

Also known as: sORP, Oxidative stress

Patients

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Abnormal sperm parameters defined as having at least two out of the following three criteria:
• Sperm Concentration \> 1 and ≤ 15 million per ml
• Sperm total Motility ≤ 40%
• Sperm Morphology by Strict Criteria; normal forms ≤ 4.0%
• Absence of infection in semen (pus cells \< 1 X 106/ml)
• No history of taking any therapy for their infertility including OTC treatment and vitamin supplementation
• No history of obstructive azoospermia
• No history of testicular cancer

You may not qualify if:

• Semen volume ≤ 1.5 mL
• Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment
• Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values:
• Testosterone \< 10.4 nmol/L
• LH \<1 or \> 9 IU/L and or FSH \<1 or \>19 IU/mL
• Elevated prolactin \>407 mIU/L
• Elevated TSH \> 4.5 U/mL
• Elevated Estrogen\> 275 pmol/L
• Leukocytospermia: WBC count of \> 1 X 106/ ml
• Known HIV infection
• Consumption of more than 1 unit of alcohol daily\*
• Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
• History of current use of illegal or "recreational" drugs
• History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma in situ which may have been curatively treated within 1 year
• Participation in another clinical trial within 30 days or 7 half-lives of the prior test product, whichever is longer

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Fairhaven Health: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Interventions

Menogaril; Antioxidants; Semen Analysis; Seeds; Oxidative Stress

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metabolism; Stress, Physiological

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, comparative study

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 14, 2018
• Study Start: January 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 14, 2018

Record last verified: 2018-01

Locations

QA (1)