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

Zavvar 2016.

Study characteristics
Methods Study design: single‐centre RCT
Country: Iran
Setting: fertility clinic
Sponsorship source: not disclosed
Trials registry number: not disclosed
Participants Inclusion criteria: women who produce only immature oocytes in spite of stimulation with gonadotropins
Exclusion criteria: not disclosed
Number of participants randomised to each arm of the study: 31 women were randomised to receive the intervention medium, and 45 were randomised to receive the control medium
Group differences: not disclosed
Fresh or frozen cycle?: not disclosed
IVF or ICSI?: ICSI
Length of time exposed to intervention medium: not disclosed
Trade name and concentration of GM‐CSF in intervention medium: MediCult 2 ng/mL
Trade name of control medium: not disclosed
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 First author contacted by email for further information on 26 November 2019 and 9 January 2020, but no response received.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description of how random sequence was generated
Allocation concealment (selection bias) Unclear risk No description of how allocation was concealed
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding was not mentioned.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding of outcome assessors was not described.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk We assessed the study as at unclear risk, as we do not have access to number of dropouts or indeed how many participants were included in the analysis.
Selective reporting (reporting bias) Unclear risk No access to a protocol or a trial registry entry
Other bias High risk Small sample size of 76 participants