Exposito 2016.
| Methods | Randomised double‐blind placebo‐controlled trial Duration of study: quote: "from January 2010 to July 2014" (information from email) |
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| Participants | Country: Spain Population: men from infertile couples participating in an IVF/ICSI program, N = 113 according to final manuscript and authors, grouped into three categories: normozoospermic, oligozoospermic and asthenozoospermic. Mean age: 37.6 ± 3.8 years Inclusion criteria: duration of infertility of at leat 12 months and female age less than 40, as this a mandatory criterion in all Spanish public hospitals Exclusion criteria: quote: "the patient does not sign the informed consent" (information from email) |
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| Interventions | Vitamin E (α‐tocopherol) 400 mg (n = 55, n = 50 completed treatment) versus Placebo (n = 59, n = 51 completed treatment) Duration of treatment: 3 months |
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| Outcomes | Sperm concentration, sperm count, progressive motility (A+B%), pregnancy rate | |
| Notes | Conference abstract. Trial registration: EudraCT 2007‐000960‐25 Email sent to author Exposito (antonia.expositonavarro@osakidetza.eus;) and Matorras (JOSEROBERTO.MATORRASWEINIG@osakidetza.eus) on 20.02.2018 and 07.03.2018 to request full text or data regarding the outcomes in the OAT/azoospermic group Reply from author Matorras on 13.03.2018, received draft of manuscript.("we hope we are able to submit it for publication in two months") and asked some more questions about design/methods and data (means with SD) on the subgroup of men with male factor (so without the normospermic men). Reply on 24.03.2018: see RoB. Data not usable in meta‐analysis due to the fact that is data for all the 3 categories (normozoospermic, oligozoospermic and asthenozoospermic) together. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote (from email): "To maintain the blindness to the investigator and the subject, the investigator receives the information of the treatment allocation number from the computer system." Computer randomisation |
| Allocation concealment (selection bias) | Low risk | Quote (from email): "To maintain the blindness to the investigator and the subject, the investigator receives the information of the treatment allocation number from the computer system. The subject receives his study medication package from the study site of the institution." Investigator receives a number belonging to a study medication package |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double‐blind". Placebo used. Quote (from email): "All the active and placebo capsules are identical in appearance, shape, smell and taste" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote (from email): "At the end 101 couples completed the treatment (placebo group N=51 and vitamin E group N=50). Nine couples withdrew from this study before completing their 3 months of treatment due to IVF cycle cancelled or a lack of continuing interest(8%) (five of the placebo group and four of the vitamin E group)(N=104) .Three couples achieved spontaneous pregnancy at 50, 60 and 90 days of treatment;two of them belonged to placebo group and the other belonged to the vitamin E group (2.7%)" Quote (from email): "The data analysis was done with the people who completed the study (n=101)" No ITT. Reasons for drop‐out well explained and balanced. |
| Selective reporting (reporting bias) | Low risk | All the outcomes from the aim of the study and methods were reported |