None listed
Conditions
Brief summary
This is a clinical trial examining the effectiveness of a vitamin supplement, Hominax, in improving sperm health. We are testing whether Hominax can improve sperm health. It is possible that Hominax can help prevent damage to sperm. Men will be allocated to receive either Hominax for 24 weeks. Sperm samples will be tested to look for a difference in sperm health between the pre- and post-treatment.
Interventions
Hominax is a TGA-listed nutraceutical containing 15 micronutrients. Each capsule contains the following:
L-carnitine 170.5mg, Acetyl-L-carnitine 84.10mg, Zinc 12.5mg, Ascorbic acid 60mg, Green tea (Camellia sinensis) 600mg, Panax ginseng root dry 500mg, Vitamin E 50IU, Lycopene 3mg, Selenium 35mg, Ubidecarenone 25mg, Vitis vinifera (grape) seed dry 600mg, Cysteine 3.4mg, Pyridoxine 2.1mg, Cyanocobalamin 5mg, Folic acid 200mg.
Dose administered will be 2 capsules by mouth, daily for 24 weeks.
Hominax is a TGA-listed nutraceutical containing 15 micronutrients. Each capsule contains the following: L-carnitine 170.5mg, Acetyl-L-carnitine 84.10mg, Zinc 12.5mg, Ascorbic acid 60mg, Green tea (Camellia sinensis) 600mg, Panax ginseng root dry 500mg, Vitamin E 50IU, Lycopene 3mg, Selenium 35mg, Ubidecarenone 25mg, Vitis vinifera (grape) seed dry 600mg, Cysteine 3.4mg, Pyridoxine 2.1mg, Cyanocobalamin 5mg, Folic acid 200mg. Dose administered will be 2 capsules by mouth, daily for 24 weeks. Compliance will be monitored by drug tablet return at 16 and 24 weeks (end of treatment).
Sponsors
Max Biocare Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20 to 60 years; 2. Evidence of a personally signed informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 3. Normal rheologic characteristics (appearance, consistency, and liquefaction) of semen, and pH in the normal range; 4. Sperm concentration between => 5 x 106/mL and at least ONE of the following within 3 months prior to screening visit: a. Sperm concentration <= 15 x 106/mL [1, 2] OR b. Progressive motility (PR, %) [1, 2] ) <= 32% OR c. Normal sperm morphology <= 4% [1, 2] on two semen samples 7-21 days apart within 3 months of enrollment into the study; 5. Seminal white blood cells <1 x 106/mL; 6. Willing to cease all vitamin and complementary medicine supplements from screening and for the duration of participation in the study; 7. Fluent in spoken & written English; 8. Patients must be accessible for treatment and follow-up; Able to swallow capsules whole; 9. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
1. Non-idiopathic infertility. That is, participants to be excluded if their infertility has a known cause such as, but not limited to: infectious genital diseases, anatomic abnormalities of the genital tract including clinical varicocele, anti-spermatozoa antibodies, taking medication with known spermicidal effects; 2. Leucocytospermia (WBC >1 x106 ml in seminal plasma); 3. Sperm concentration < 5 x 106/mL in the semen sample used to confirm male factor infertility to exclude severe condition; 4. Smoking if greater than or equal to 1 pack per week (on average), a. Alcohol if greater than or equal to 20 grams alcohol (equivalent to 2 standard drinks, on average, per day) or b. Drug addiction to any substance, and occupational chemical exposure; 5. If diagnosed with a bleeding disorder; or hypothyroidism; or seizures; or HIV/AIDs; or hepatitis of any cause; or an autoimmune disease; or planning to have angioplasty during the study; 6. If taking thyroid hormone, or anti-coagulant or anti-platelet medication, or anti-seizure medication, or HIV/AIDs medication; or barbiturates; 7. Has known allergies or hypersensitivities to the components of Hominax or capsule excipients. 8. Has a history of gastrointestinal condition and/or experiences adverse reactions to swallowing medications (e.g. vomiting, reflux etc.) and / or during digestion of medications after consumption (e.g. acute diarrhoea/constipation; abdominal cramps; occult blood etc.) 9. Has significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic or haematological disorders; 10. Diabetes Mellitus requiring insulin therapy; 11. Has current psychiatric illness or dementia (excluding clinically diagnosed depression or anxiety where the patient has been stable on medication for at least three months); 12. Any serious medical or psychological disorders likely to preclude completion of the study.
Outcome results
None listed