Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001068257p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2018
Date registered
26/06/2018
Date last updated
19/10/2020
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Blackmore’s Conceive Well Men vs placebo in men with low sperm count and motility
Scientific title
A double-blind, randomised controlled trial on the efficacy of Blackmore’s Conceive Well Men in men with oligozoospermia and asthenozoospermia
Secondary ID [1] 295240 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
CONTROLAS (COnceive Well Men TReatment of OLigozoospermia and ASthenozoospermia) study.
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Oligozoospermia (low sperm concentration) 308408 0
Asthenozoospermia (low sperm motility) 308409 0
Condition category
Condition code
Reproductive Health and Childbirth 307399 307399 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: CONTROLAS (COnceive Well Men TReatment of OLigozoospermia and ASthenozoospermia) study
The drug is, Conceive Well Men (ARTG ID: 232543), it’s a conventional antioxidant supplement preparation in tablet form with the following active ingredients per tablet:
Ascorbic acid (vitamin C) 250 milligrams
Cholecalciferol (vitamin D3) 15 micrograms
Cyanocobalamin (vitamin B12) 33 micrograms
d-alpha-Tocopheryl (vitamin E) 67.07 milligrams
Folic acid 450 micrograms
Selenomethionine (selenium) 372 micrograms
Ubidecarenone (coenzyme Q10) 45 milligrams
Ubiquinol-10 (ubiquinol) 45 milligrams
Zinc amino acid chelate (zinc) 75 milligrams

For the intervention, the dose: 3 tablets daily, the duration: 6 months, and the mode: oral tablet.

Intervention adherence will be assessed by these monthly followup calls that HX makes to the participants, the 3rd and 6th month study visits by HX will check on the participant’s medication intake by tablet count.
Intervention code [1] 301578 0
Treatment: Drugs
Comparator / control treatment
Glucose capsule, taken 2 tablets daily for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 306369 0
Sperm concentration (million/mL)
Timepoint [1] 306369 0
Baseline, 3 months post-baseline and 6 months post-baseline (primary timepoint)
Primary outcome [2] 306370 0
Sperm total motility (%)
Timepoint [2] 306370 0
Baseline, 3 months post-baseline and 6 months post-baseline (primary timepoint)
Secondary outcome [1] 348276 0
Pregnancy of participants partners (positive/negative) by urine test. This test and its results are performed and derived by the subject's partners.
Timepoint [1] 348276 0
3 months post-baseline and 6 months post-baseline
Secondary outcome [2] 348618 0
Sperm morphology (%)
Timepoint [2] 348618 0
3 months post-baseline and 6 months post-baseline

Eligibility
Key inclusion criteria
1. Gender: Men
2. Men with female partners who are interested in conceiving
3. A semen analysis in the previous 3 months that result in a sperm count of less than 15 million/ml or sperm motility of less than 30%
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. On antioxidant supplements, iron, folic acid or omega three supplements or any nutritional male fertility supplements that affect semen quality in the previous 3 months
2. Had surgical male fertility treatment in medical history

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computerised randomisation using a software
Masking / blinding
Blinded (masking 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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intended sample size for the project is 100. This study is a RCT and to set the sample size in the range of sample sizes from similar RCTs in PubMed will justify the aims of this study, because the other sample sizes have justified those similar RCTs in PubMed. There are 6 PubMed RCTs investigating the efficacy of antioxidants in managing male infertility in the form of low sperm count and low sperm motility. The sample size of these RCTs range from 31 to 173. Therefore a sample size of 100 was selected, because 5 out of 6 RCTs had sample sizes less than this magnitude. To confirm the justification, a power calculation using the result data from one of these RCTs (Suzuki et al. 2003), where the sample size was set to 100, returned 79%. Therefore an intended sample size of 100 is justified. The contingency plan for participant drop out rates is to replace these drop outs with new recruits until the 100 sample size is complete.

The statistical method, ANOVA will compare the active and placebo participant semen parameters to the baseline descriptors. The baseline descriptors will show the means and standard deviations for continuous variables, and frequencies and percentages for categorical variables.

Reference:
Suzuki M, Kurabayashi T, Yamamoto Y, Fujita K and Tanaka K 2003, ‘Effects of antioxidant treatment in oligozoospermic and asthenozoospermic men’, The Journal of Reproductive Medicine, vol. 48, no. 9, pp. 707-712.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
31/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11179 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 23020 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 299830 0
Commercial sector/Industry
Name [1] 299830 0
Blackmores
Country [1] 299830 0
Australia
Primary sponsor type
Individual
Name
Michael Chapman
Address
High Street, University of New South Wales, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 299184 0
Individual
Name [1] 299184 0
Michael Chapman
Address [1] 299184 0
Suite 15, Level 3, 1 South Street, St George Private Hospital, Kogarah NSW 2217
Country [1] 299184 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300708 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 300708 0
Human Ethics Office, Gate 2, High Street, University of New South Wales, Sydney NSW 2052
Ethics committee country [1] 300708 0
Australia
Date submitted for ethics approval [1] 300708 0
21/05/2018
Approval date [1] 300708 0
Ethics approval number [1] 300708 0

Summary
Brief summary
This will be a double-blind, randomised, placebo-controlled clinical trial. The primary aim of this trial is to assess whether an over-the-counter (OTC) nutritional supplement can improve sperm quality in 100 men and the pregnancy rates of their partners when compared to the placebo for 6 months. All participants will take 3 capsules per day for 6 months or 180 days, a total of 540 capsules/participant. Changes in quality will be based upon sperm concentration or motility. This OTC supplement, called “Conceive Well Men”, will be donated free-of-charge by Blackmores. The supplement is produced under the good manufacturing practice (GMP) and meets TGA standards as a ‘listed’ product, which indicates safety and quality. The importance of undertaking this project is to emphasise the role of sperm health as male infertility has become an increasing factor in managing infertility.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2778 2778 0 0
/AnzctrAttachments/375374-Patient Information And Consent Form.pdf

Contacts
Principal investigator
Name 84554 0
Mr Michael Chapman
Address 84554 0
High Street, University of New South Wales, Kensington NSW 2052
Country 84554 0
Australia
Phone 84554 0
+61 473829105
Fax 84554 0
Email 84554 0
michaelchapman5940@outlook.com
Contact person for public queries
Name 84555 0
Michael Chapman
Address 84555 0
High Street, University of New South Wales, Kensington NSW 2052
Country 84555 0
Australia
Phone 84555 0
+61 473829105
Fax 84555 0
Email 84555 0
michaelchapman5940@outlook.com
Contact person for scientific queries
Name 84556 0
Michael Chapman
Address 84556 0
High Street, University of New South Wales, Kensington NSW 2052
Country 84556 0
Australia
Phone 84556 0
+61 473829105
Fax 84556 0
Email 84556 0
michaelchapman5940@outlook.com

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.