Obidniak 2016.
Study characteristics | ||
Methods | RCT Single centre Russia |
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Participants | Women undergoing frozen embryo transfer. Inclusion criteria:
Exclusion criteria:
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Interventions | 3 arms: Group 1 (N = 40): intrauterine perfusion with G‐CSF (filgrastim 30 mIU, 1 mL) using insemination catheter 5 days prior to embryo transfer (intervention arm) Group 2 (N = 30): G‐CSF (filgrastim 30 mIU, 1 mL) was administered subcutaneously once at the day of embryo transfer (intervention arm) Group 3 (N = 60): no therapy (control arm) |
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Outcomes | Implantation rates, clinical pregnancy rates | |
Notes | Conference abstract. No clinical registration number available. Authors could not be contacted. Doses of G‐CSF stated in the abstract to be 30 million IU; FDA information suggests dose of 300 mcg/mL which is equivalent to 30 milli‐international units (mIU); intervention text amended accordingly. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Three groups was formed on the basis of randomisation" Method of randomisation not mentioned. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel not mentioned. Assessed as high risk as the control arm had no placebo treatment or sham procedure. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Does not specify if outcome assessors were blinded. However, absence of blinding is unlikely to have influenced the findings for our primary and secondary outcomes, hence categorised as low risk for detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all participants were considered in the reporting of results. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit a judgement |
Other bias | Unclear risk | Insufficient information to permit a judgement |