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) |
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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 |
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Interventions |
Intervention: GM‐CSF‐supplemented culture medium Control: standard IVF medium |
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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 |