Antinori 2008.
| Methods | Randomised controlled trial conducted in a private assisted reproduction centre (Italy). Period of enrolment not reported. | |
| Participants | Inclusion criteria: at least 2 previous diagnoses of severe oligoasthenospermia; 3 years of primary infertility; absence of female factor. | |
| Interventions | Couples were randomised into 2 groups: Intervention: oocytes injected with spermatozoon selected under ultra‐high magnification (IMSI): on the basis of MSOME criteria, the examination and spermatozoa selection for IMSI procedure was performed in real time using an inverted light microscope equipped with high‐power Nomarski optics, enhanced by digital imaging to achieve a magnification up to 6300x, and the Eppendorf Micromanipulation System (Transfer‐Man NK2, Eppendorf, Germany). Only spermatozoa with normal head dimension (length 4.75 ± 0.28 μm; width 3.28 ± 0.20 μm), and shape, with no, or maximum 1 vacuole (0.78 ± 0.18 μm) microinjected; spermatozoa with abnormal head size were excluded (such spermatozoa were identified by superimposing a transparent celluloid form representing the correct spermatozoon size on the examined gametes). 2 spermatozoa for each oocyte were selected for insemination, using the classical ICSI technique. Control: oocytes injected with spermatozoon selected under regular magnification (ICSI): no further details. |
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| Outcomes | Clinical pregnancy, miscarriage, and implantation rates | |
| Notes | We considered 2 publications to be related to the same study; although the number of couples was not the same, the only difference we observed was that the newer publication had evaluated more couples; the authors did not answer our e‐mails to resolve these data queries. Live birth and congenital abnormalities not reported Implantation rate: 23.0% (IMSI) vs 16.6% (ICSI); P value not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes prepared by a research nurse |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All study participants were blinded to treatment assignment for the duration of the study |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Not suspected |
| Other bias | Low risk | None |