Blackmore’s Conceive Well Men vs placebo in men with low sperm count and motility
A double-blind, randomised controlled trial on the efficacy of Blackmore’s Conceive Well Men in men with oligozoospermia and asthenozoospermia
Michael Chapman
100 participants
Aug 31, 2018
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- Gender: Men
- Men with female partners who are interested in conceiving
- 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%
Exclusion Criteria2
- 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
- Had surgical male fertility treatment in medical history
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Interventions
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.
Locations(1)
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ACTRN12618001068257