Micic 2017.
| Methods | Randomised double‐blind placebo‐controlled trial Duration of study: unclear |
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| Participants | Country: Serbia Population: men with oligo‐asthenozoospermia, N = 175 Mean age: unclear Inclusion criteria: men visiting the Andrology center, (18‐50 years) and with difficulty in conceiving > 12 months Exclusion criteria: unclear |
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| Interventions | Proxeed Plus (L‐carnitine 2 g, acetyl‐L‐carinitine 1 g, vitamins and minerals) (n = 125) versus Placebo (n = 50) Duration of treatment: 6 months (and 2 months wash‐out) |
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| Outcomes | Progressive motility, seminal plasma carnitine | |
| Notes | Conference abstract only. Email sent to last author Agarwal (AGARWAA@ccf.org) on 20.02.2018. Answer on 21.02.18 "this study is not published in a journal at this time" New email on 06.03.2018 to ask raw data (means with SD) and more information about randomisation/blinding outcome/dropout rates. Reply on 22.03.18 from Agarwal & Micic (savamicic2016@gmail.com) with more information in a word document. Only medians with IQR. See RoB. Data not usable, medians with IQR. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote (from email): "Random list was made using the nQuery Advisor nTerim 2.0 (2012) program" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (from email): "This is a double blind study. Neither the patient, providers, nor investigators responsible for collecting data or analyzing laboratory specimens have been knowledgeable regarding the assignment of active or placebo product. A file has been maintained at each of the sites under the responsibility of the primary investigator which will provide product identification for each subject. Upon entry into the study, subjects have been assigned a unique study identification number." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (from email): "Neither the patient, providers, nor investigators responsible for collecting data or analyzing laboratory specimens have been knowledgeable regarding the assignment of active or placebo product. " |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote (from email): "From the treated group (total 125 ) drop out was 6 subjects; 2 of them got flu with high temperature, 2 went form Serbia (new job), 2 stopped without reason. And from the placebo group ( total 5o ) drop out was 4; 2 drop out without explanation , 1 underwent abdominal surgery, and 1 divorced" |
| Selective reporting (reporting bias) | Unclear risk | Abstract only |