Oxidative Stress In Semen And Male Infertility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03464656|
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Antioxidants Infertility, Male Semen Quality||Drug: Fairhaven Pro for men Diagnostic Test: Semen analysis Diagnostic Test: Sperm DNA fragmentation Diagnostic Test: Static Oxidation reduction potential in semen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-center, prospective, comparative study|
|Masking:||None (Open Label)|
|Official Title:||Oxidative Stress In Semen And Male Infertility|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study.
Drug: Fairhaven Pro for men
Fairhaven Pro for men
The antioxidant formula (Fairhaven Health) contains:
Other Name: Antioxidant
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).
Other Name: Semen test
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%
Other Name: SDF
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.
- Evaluate the effect of antioxidant therapy on sperm motility in infertile men, [ Time Frame: 1 year ]Measured by mean change in sperm motility pre- and post-treatment with antioxidants.
- Evaluate the effect of antioxidant therapy on sperm morphology in infertile men [ Time Frame: 1 year ]Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants
- Evaluate the effect of antioxidant therapy on sperm count in infertile men [ Time Frame: 1 year ]Measured by mean change in sperm count pre- and post-treatment with antioxidants.
- Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men [ Time Frame: 1 year ]Difference in mean change in sperm DNA fragmentation pre and post-treatment
- Evaluate the effect of antioxidant therapy on oxidative stress in infertile men [ Time Frame: 1 year ]Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464656
|Hamad Medical Corporation||Recruiting|
|Contact: Mohamed Arafa, MD +97455198169 email@example.com|
|Contact: Haitham Elbardisi, MD +97455892698 firstname.lastname@example.org|
|Principal Investigator: Mohamed M Arafa, MD|
|Sub-Investigator: Haitham T Elbardisi, MD|
|Sub-Investigator: Sami S Alsaid, MD|
|Sub-Investigator: Ahmad A Majzoub, MD|