Open-label prospective multi-centre study to examine the effect and safety of the non-prescription nutraceutical product FTC0098 (pollen extract) on semen quality and sperm health.

Exclusion Criteria12

• Participants are to be excluded if their male 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, and taking medication with known spermicidal effects.
• Leucocytospermia (WBC >1 x106 ml in seminal plasma);
• Sperm concentration < 5 x 106/mL in the semen sample used to confirm male factor infertility to exclude severe conditions.
• Smoking and vaping (tobacco if greater than or equal to 1 pack of cigarettes per week on average).
• Alcohol if greater than or equal to 20 grams alcohol (equivalent to 2 standard drinks, on average, per day) or recreational drug use to any substance, and occupational chemical exposure.
• 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.
• If taking thyroid hormone, or anti-coagulant or anti-platelet medication, or anti-seizure medication, or HIV/AIDs medication; or barbiturates.
• Has known allergies or hypersensitivities to the components of the nutraceutical product FTC0098 or capsule excipients.
• Has a history of gastrointestinal conditions and/or experiences adverse reactions to swallowing medications (e.g. vomiting, reflux, etc) and/or during digestion of medications after consumption (e.g. acute diarrhea/constipation, abdominal cramps, occult blood, etc).
• Has significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic or haematological disorders.
• Diabetes requiring insulin therapy.
• Any serious medical or psychological disorders likely to preclude completion of the study.