Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000194460
Ethics application status
Approved
Date submitted
8/02/2016
Date registered
15/02/2016
Date last updated
11/11/2020
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hominax for improving sperm health
Scientific title
A pre and post study of the effect and safety of Hominax to improve sperm health
Secondary ID [1] 288496 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sperm health 297557 0
Alternative and complementary medicine 297588 0
Condition category
Condition code
Reproductive Health and Childbirth 297758 297758 0 0
Fertility including in vitro fertilisation
Alternative and Complementary Medicine 297783 297783 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 293860 0
Treatment: Other
Comparator / control treatment
No control (or placebo) treatment will be used in this study, all enrolled participants will be receiving the active treatment (i.e., Hominax). This change was made at the conclusion of the RCT (i.e., after recruiting 7 participants) and we are now recruiting male volunteers to be part of the open-label study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297289 0
Change in sperm concentration by semen sample
Timepoint [1] 297289 0
Between screening and weeks 16 and 24 (end of treatment)
Primary outcome [2] 297290 0
Change in sperm progressive motility by semen sample
Timepoint [2] 297290 0
Between screening and weeks 16 and 24 (end of treatment)
Primary outcome [3] 297291 0
Change in morphologically normal sperm by semen sample
Timepoint [3] 297291 0
Between screening and weeks 16 and 24 (end of treatment)
Secondary outcome [1] 320630 0
Number of confirmed pregnancies by pregnancy test (urine initially then confirmed with quantitative serum hCG)
Timepoint [1] 320630 0
Between baseline, week 16, week 24 (end of treatment) and week 36
Secondary outcome [2] 320631 0
Change in lipid peroxidation of seminal plasma and sperm
Timepoint [2] 320631 0
Between screening and weeks 16 and 24 (end of treatment)
Secondary outcome [3] 320633 0
Change in sperm DNA fragmentation by semen sample
Timepoint [3] 320633 0
Between screening and weeks 16 and 24 (end of treatment)
Secondary outcome [4] 320634 0
Change in semen volume
Timepoint [4] 320634 0
Between screening and weeks 16 and 24 (end of treatment)
Secondary outcome [5] 320635 0
Change in semen pH
Timepoint [5] 320635 0
Between screening and weeks 16 and 24 (end of treatment)
Secondary outcome [6] 320636 0
Change in homocysteine levels by blood sample
Timepoint [6] 320636 0
Between screening and week 24 (end of treatment)
Secondary outcome [7] 320637 0
Frequency of adverse events as recorded on an Adverse Events Log. The expected adverse event profile of Hominax is a combination of adverse events reported for its components, namely: constipation, diarrhoea, nausea, vomiting, headache, restlessness, stomach discomfort, loss of appetite, tremors, insomnia, shortness of breath, mild upper gastrointestinal tract infection, allergic reaction, irritability, heartburn, chest tightness, fatigue, paraesthesia, nosebleeds, decreased urine, rapid pulse, cough, heart palpitations, increased sweating. The expected rate for each of these adverse events is infrequent and the expected severity is mild to moderate. Hominax is considered relatively safe with no drug related serious adverse events expected at the prescribed dose.
Timepoint [7] 320637 0
Baseline, weeks 2, 16, 24, and 26
Secondary outcome [8] 320689 0
Change in vitamin B12 levels by blood sample
Timepoint [8] 320689 0
Between screening and week 24
Secondary outcome [9] 320690 0
Change in zinc levels by blood sample
Timepoint [9] 320690 0
Between screening and week 24
Secondary outcome [10] 320691 0
Change in RBC folate levels by blood sample
Timepoint [10] 320691 0
Between screening and week 24
Secondary outcome [11] 320692 0
Severity of adverse events recorded on an Adverse Events Log, severity will be graded by the investigator according to NCI CTCAE Version 4.0 (Grades 1-5)
Timepoint [11] 320692 0
Baseline, weeks 2, 16, 24, 26

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers will be used. Bottles will be labelled with sequential randomisation ID numbers prior to the start of the trial, and each subsequent participant will be allocated the next consecutive randomisation ID number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be computer-generated by an independent researcher, The randomisation code will be held by an independent researcher. None of the investigators in the trial will have privy to this code until data analysis is complete.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We assume that the active treatment will improve concentration, morphology and motility simultaneously. We set the lower limit of clinical significance of these improvements at 0.5 standard deviations; which we estimate to be simultaneous improvement in average concentration from 15 x106 to 20 x106, in morphology from 4% to 6% and in forward motility from 30% to 40%. We assume 0.3 correlation between each of concentration, morphology and motility and 0.5 correlation between baseline and follow-up measures. Morphology is scored between 0 to 100 per person indicating the proportion of sperm with healthy shape morphology. Similarly motility is scored between 0 and 100 per person indicating the proportion of sperm demonstrating good forward movement. Analysis will be conducted using multivariate methods (such as MANOVA). In order to detect a clinically significant improvement in sperm quality with 80% power at the 0.05 significance level requires a total sample size of 98 completed participants which requires 122 randomised participants (61 per group) to allow for an estimated 20% withdrawal rate during the study.

Secondary analyses on single outcome variables will have 80% power to detect a 0.6 standard deviation greater improvement in the treatment group than the placebo.

Analyses of semen quality will be conducted using multivariate methods (such as MANOVA) and secondary analyses on individual outcomes will be conducted using the equivalent ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
20/12/2016
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 292853 0
Commercial sector/Industry
Name [1] 292853 0
Max Biocare Pty Ltd
Country [1] 292853 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Max Biocare Pty Ltd
Address
Level 1 & 2, 667 Chapel St, South Yarra VIC 3141
Country
Australia
Secondary sponsor category [1] 291597 0
None
Name [1] 291597 0
Address [1] 291597 0
Country [1] 291597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294351 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 294351 0
Ethics committee country [1] 294351 0
Australia
Date submitted for ethics approval [1] 294351 0
09/11/2015
Approval date [1] 294351 0
09/02/2016
Ethics approval number [1] 294351 0
H11411
Ethics committee name [2] 294352 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 294352 0
Ethics committee country [2] 294352 0
Australia
Date submitted for ethics approval [2] 294352 0
24/11/2015
Approval date [2] 294352 0
Ethics approval number [2] 294352 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63378 0
Dr Carolyn Ee
Address 63378 0
NICM Health Research Institute
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797 PENRITH NSW 2751
Country 63378 0
Australia
Phone 63378 0
+61 2 4620 3085
Fax 63378 0
Email 63378 0
[email protected]
Contact person for public queries
Name 63379 0
Mahmoud Al-Dabbas
Address 63379 0
NICM Health Research Institute
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797 PENRITH NSW 2751
Country 63379 0
Australia
Phone 63379 0
+61 414 357 363
Fax 63379 0
Email 63379 0
[email protected]
Contact person for scientific queries
Name 63380 0
Carolyn Ee
Address 63380 0
NICM Health Research Institute
Western Sydney University
Building J, Westmead Campus
Locked Bag 1797 PENRITH NSW 2751
Country 63380 0
Australia
Phone 63380 0
+61 2 4620 3085
Fax 63380 0
Email 63380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.