Setti 2012b.

Methods	Prospective randomised clinical trial performed in a private fertility centre (Brazil). Period of enrolment not reported.
Participants	Eligibility criteria: women of good physical and mental health; undergoing ICSI as a result of advanced maternal age (≥ 37 years old); with regular menstrual cycles of 25 to 35 days; normal basal FSH and LH concentrations; body mass index < 30 kg/m²; presence of both ovaries and intact uterus; absence of PCOS, endometriosis, and gynaecological or medical disorders; and a negative result in screening for sexually transmitted diseases. All male partners were normozoospermic, according to the WHO reference values (2010). No woman had received any hormone therapy for at least 60 days preceding the study.
Interventions	Couples were randomised into 2 groups: Intervention: sperm selection in the IMSI group was analysed under high magnification using an inverted Nikon Diaphot microscope equipped with high‐power DIC optics. The total calculated magnification was 6600x. An aliquot of the sperm cell suspension was transferred to a microdroplet of modified human tubal fluid medium containing 8% polyvinyl pyrrolidone (Irvine Scientific, Santa Ana, CA, USA) in a sterile glass dish (FluoroDish; World Precision Instrument, Sarasota, FL, USA). The dish was placed on a microscope stage above an Uplan Apo 100 oil/1.35 objective lens previously covered by a droplet of immersion oil. The sperm cells that were selected for injection exhibited normally shaped nuclei (smooth, symmetric, and oval configuration) and normal nuclear chromatin content (if it contained no more than 1 vacuole that occupied < 4% of the nuclear area). Control: sperm selection in the ICSI group was analysed under 400x magnification using an inverted Nikon Eclipse TE 300 microscope
Outcomes	Fertilisation rate, high‐quality embryo rate on day 3, blastocyst formation rate, number of transferred embryos, implantation rate, miscarriage rate, and pregnancy rate
Notes	Live birth and congenital abnormalities not reported Implantation rate: 38.3% (IMSI) vs 12.1% (ICSI). P = 0.03 This article was withdrawn from one journal and republished in another one later on. Authors were contacted for more information regarding the reasons for this. Authors were also contacted to clarify information about the 4 different included studies, from the same groups of authors (Figueira 2011; Setti 2011; Setti 2012a; Setti 2012b). All questions on methods of randomisation, patient overlapping and data per woman were clarified.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation table
Allocation concealment (selection bias)	Unclear risk	Authors stated allocation sequence was concealed, but no further information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The allocation sequence was concealed from the participant.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Primary study team was not blinded to the intervention.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss of follow‐up
Selective reporting (reporting bias)	Low risk	Not suspected
Other bias	High risk	Although there was no significant difference in the number of oocytes retrieved, and despite the total number of embryos being higher in the ICSI group, more embryos per woman were transferred in the IMSI group. This article has been withdrawn and republished in another journal.

DIC: differential interference contrast; FISH: fluorescent in situ hybridisation; FSH: follicle‐stimulating hormone; HA: hyaluronate; HCl: hydrochloric acid; ICSI: intracytoplasmic sperm injection; IMSI: intracytoplasmic morphologically selected sperm injection; IVF: in vitro fertilisation; LH: luteinising hormone; MSOME: motile sperm organella morphology examination; PCOS: polycystic ovaries syndrome; SD: standard deviation; WHO: World Health Organization.