Barad 2014.
Study characteristics | ||
Methods | RCT Single centre USA |
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Participants | Women aged 18 to 38 years with normal endometrium undergoing fresh IVF. Exclusion criteria: women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible for medical reasons. |
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Interventions | Intervention arm (N = 73): G‐CSF used was Nupogen (300 μg/1.0 mL, filgrastim; Amgen) Control arm (N = 68): placebo used (normal saline) 1 mL of G‐CSF or placebo (normal saline) was administered on the morning of hCG administration before noon by slow transcervical intrauterine infusion, similar in technique to an intrauterine insemination. Endometrial thickness was assessed by routine vaginal ultrasound before infusion and again 5 days later at the time of embryo transfer. Only data from pre‐cross‐over phase of the study was included. |
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Outcomes | Clinical pregnancy rate, implantation rate, miscarriage rate | |
Notes | Registered trial (NCT01202656). We contacted authors for clarification, who responded with data clarification and provided other details. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated randomisation table was used with separate randomisation blocks for women undergoing IVF and frozen‐embryo transfer in the first study cycle. |
Allocation concealment (selection bias) | Low risk | Individual randomisation cards were sealed in numbered, opaque envelopes that were only accessible to the single staff member who administered the randomisation table and prepared the study materials. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Treatment assignment was blinded to participants, physicians, and nursing staff. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome assessors were also blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts during the first phase of the treatment, therefore considered to be at low risk of attrition bias |
Selective reporting (reporting bias) | High risk | Live birth as a prespecified outcome (as per trial registry file) was not reported in the published manuscript. |
Other bias | Low risk | None; funding mentioned (Foundation for Reproductive Medicine, a not‐for‐profit medical research foundation, and by intramural funds from the Center for Human Reproduction). No difference in baseline characteristics |