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. 2020 Jul 16;2020(7):CD013497. doi: 10.1002/14651858.CD013497.pub2

Zafardoust 2017.

Study characteristics
Methods Study design: single‐centre RCT
Country: Iran
Setting: fertility clinic
Sponsorship source: infertility and recurrent abortion treatment centre of Avicenna
Trials registry number: www.irct.ir/trial/11703 (registered during recruitment)
Participants Inclusion criteria: couples undergoing treatment with their own gametes, women aged < 40 years old, women with at least 4 good‐quality embryos after thawing (grade A), women who had not had more than 1 previous embryo transfer
Exclusion criteria: cycles requiring pre‐implantation genetic diagnosis, women with an anatomic disorder of the uterus or hydrosalpinx/hydrosalpinges
Number of participants randomised to each arm of the study: number randomised to each arm before dropout was not disclosed
Group differences: the average age between the 2 groups differed
Fresh or frozen cycle?: frozen cycles
IVF or ICSI?: ICSI
Length of time exposed to intervention medium: from embryo thawing through to embryo transfer
Trade name and concentration of GM‐CSF in intervention medium: BlastGen 2 ng/mL
Trade name of control medium: Vitrolife, USA
Day of embryo transfer: not disclosed
Number of embryos transferred: not disclosed
Interventions Intervention: GM‐CSF‐supplemented culture medium
Control: standard IVF medium
Outcomes Clinical pregnancy rate
Notes Emailed on 29 October 2019, 26 November 2019, and 9 January 2020 for further information, but received no response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description of how randomisation was undertaken
Allocation concealment (selection bias) Unclear risk No description of how allocation concealment was undertaken
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No description of who, if anyone, was blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding of outcome assessors not described
Incomplete outcome data (attrition bias)
All outcomes High risk 10 women were not included in the final analysis, which is a high rate of attrition.
Selective reporting (reporting bias) High risk No data on miscarriage, multiple pregnancy, and beta human chorionic gonadotrophin (BHCG) levels, which are secondary outcomes noted on trials register
Other bias High risk Small sample size of 90 participants