Mehni 2014.
| Methods | Randomised double‐blind, placebo‐controlled trial Duration of study: from May 2008 to August 2012 |
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| Participants | Country: Iran Population: infertile men with idiopathic OAT, N = 235 Mean age: treatment (L‐carnitine) group 30 ± 1.7 years, control group 30 ± 4.6 years Inclusion criteria: age 25 – 40 years, infertile men with OAT, healthy fertile wives Exclusion criteria: existence of genital abnormalities (undescended testes, varicocele, atrophy of testes), occupational chemical exposure history, systemic diseases, abnormal semen volume, pH, agglutination or viscosity, derum hormonal abnormalities (FSH, LH, testosterone, estradiol, prolactin), wives with known fertility risk factors confirmed by gynecologist |
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| Interventions | Pentoxifylline 800 mg + L‐carnitine 1000 mg (n = 58) versus Pentoxifylline 800 mg + Placebo (n = 59) versus L‐carnitine 1000 mg + Placebo (n = 59) versus Placebo (n = 59) Duration of treatment: 3 months |
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| Outcomes | Sperm parameters (progressive sperm motility), selection of type of assisted reproductive techniques (ART) | |
| Notes | Only data from L‐carnitine and placebo arm used. Email sent to author (dr.ketabchi@gmail.com) on 06.03.2018 to ask about the randomisation process and blinding of the outcome assessment Reminder email sent to Ketabchi on 22.03.2018. No reply to date (19.04.2018). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized by Bloch method to four groups" Bloch (block?) method, does this mean computerised? Insufficient explanation |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double‐blind". Placebo used. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "After intervention 23 patients excluded from study (3 patients for drug intolerance in group I, and 20 patients for uncooperative in group II and III)" Data‐analysis only with for those who completed the study (N = 212) According to figure 1: 5 patients (instead of 3 mentioned in text) dropped out due to drug intolerance in group I? Type error? Reasons and exact numbers for dropout not given for L‐carnitine arm specifically. |
| Selective reporting (reporting bias) | Unclear risk | All the outcomes from the aim of the study and methods were reported. No protocol available. |