A Phase 4 interventional study of Fairhaven Pro for men and Semen analysis in Antioxidants, Infertility, Male and Semen Quality, sponsored by Hamad Medical Corporation. Status unknown at 1 site in Qatar. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by Hamad Medical Corporation · Phase 4, Interventional, and Treatment
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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.
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Several studies have been conducted to evaluate the effect of many antioxidant regimens on male infertility. A randomized double-blind, placebo-controlled trial investigated a combined antioxidant regimen, including vitamin C, using Menevit (lycopene 6mg, vitamin E 400IU, vitamin C 100mg, zinc 25mg, selenium 26 mcg, folate 0.5mg, garlic 1g) in couples undergoing intracytoplasmic sperm injection. The authors reported a significant improvement in viable pregnancy rate in the treatment group, where 38.5% of transferred embryos resulted in a viable fetus compared to 16% in the placebo group (Tremellen K, 2007). Suleiman et al. studied 300 mg of daily vitamin E in a placebo-controlled study revealing significant improvement in sperm motility and reduction of oxidative stress measures in the treatment group. Moreover, they reported a 21% spontaneous pregnancy rate in the treatment group compared to 0% in the placebo group (Suleiman SA, 1996).
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. No other procedures will be done for research purposes. All other investigations or treatments will be given according to the standard of care. Routinely patients presenting to the male infertility unit at HMC seeking evaluation and treatment for delayed conception will be assessed with a history and physical examination, investigated with semen and endocrine studies and be placed on an antioxidant regimen comprised of vitamins C and E, L-Carnitine and pentoxyfylline. Further management will be individualized and planned according to each patient's condition.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 187 interventional studies indexed under Infertility, Male.
Browse Infertility, Male studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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:
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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.
Time frame: 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
Time frame: 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.
Time frame: 1 year
Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men
Difference in mean change in sperm DNA fragmentation pre and post-treatment
Time frame: 1 year
Evaluate the effect of antioxidant therapy on oxidative stress in infertile men
Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment.
Time frame: 1 year
Started Jan 2018 (actual). Primary completion is estimated for Jul 2018, 6 months after the start.
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Studies of the drug tested here: Antioxidants