None listed
Conditions
Brief summary
This study will help researchers to understand if supplement FTC0098 improves sperm quality in men undergoing fertility treatment by investigating its safety and efficacy. It is known that for couples who are trying to become pregnant, the male factor can be responsible for up to 50% of these cases. Therefore, this study aims to evaluate the effect of antioxidant supplements on improving semen quality as measured by semen analysis and DNA damage studies. Each participant takes the daily supplement for 16 weeks and will be asked to produce three semen samples throughout the duration of the study. .
Interventions
Name : Nutraceutical product FTC0098 capsule. Pollen extracts (Complex ) 320mg
Dose : 1 capsule every morning orally,
Provider: Serelys Pharmaceutical Company
Duration of administration: 16 weeks
How: We will see each participant face to face to dispense the study capsules
Where: Fertility and Research Centre, Randwick, Sydney & City Fertility, CBD, Sydney
When and How Much: 1 capsule a day over 16 weeks.
Tailoring: Nil titration or adaptations involved.
How Well: Particpants will be counsell
Name : Nutraceutical product FTC0098 capsule. Pollen extracts (Complex ) 320mg Dose : 1 capsule every morning orally, Provider: Serelys Pharmaceutical Company Duration of administration: 16 weeks How: We will see each participant face to face to dispense the study capsules Where: Fertility and Research Centre, Randwick, Sydney & City Fertility, CBD, Sydney When and How Much: 1 capsule a day over 16 weeks. Tailoring: Nil titration or adaptations involved. How Well: Particpants will be counselled to be compliant by setting daily reminders, to prevent missing a dose. They will also be given a diary to assist them with this. A compliance count of capsules will be conducted at the end of their participation.
Sponsors
UNSW Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 20 to 60 years of age 2. Evidence of a signed informed consent form indicating that the participant has been informed of all pertinent aspects of the study. 3. Semen analysis with normal rheologic characteristics (appearance, consistency, and liquefaction) of semen, and pH in the normal range. 4. Semen-analysis with sperm concentration greater than or equal to 5 x 106/mL and less than or equal to 15 x 106/mL within 3 months before the screening visit; OR progressive motility (PR, %) greater than or equal to 32%, OR normal sperm morphology less than or equal to 4% on two semen samples 7-21 days apart within 3 months of enrolment into the study. Data will be screened by research nurses to check for eligibility. 5. Semen analysis with seminal white blood cells. 6. Partnered with women equal or older than 37 years old.
Exclusion criteria
1. 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. 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 conditions. 4. Smoking and vaping (tobacco if greater than or equal to 1 pack of cigarettes per week on average). 5. 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. 6. 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. 7. If taking thyroid hormone, or anti-coagulant or anti-platelet medication, or anti-seizure medication, or HIV/AIDs medication; or barbiturates. 8. Has known allergies or hypersensitivities to the components of the nutraceutical product FTC0098 or capsule excipients. 9. 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). 10. Has significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic or haematological disorders. 11. Diabetes requiring insulin therapy. 13. Any serious medical or psychological disorders likely to preclude completion of the study.
Outcome results
None listed