Hominax for improving sperm health

Not Applicable

Recruiting

• Conditions: Sperm health; Alternative and complementary medicine; Reproductive Health and Childbirth - Fertility including in vitro fertilisation; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12616000194460
• Lead Sponsor: Max Biocare Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-15
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 62

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified