NCT01202643.
Study characteristics | ||
Methods | RCT Single centre USA |
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Participants | Female IVF patients aged between 21 and 45 years who were willing to be randomised to treatment and, in either IVF treatment, FET or donor IVF cycles, 5 days before ET, and have inadequate endometrial thickness (< 7 mm). Exclusion criteria:
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Interventions | Intervention group (N = 6): G‐CSF 300 mcg/mL administered by transcervical infusion 1 time on day of hCG trigger for ovulation Control group (N = 6): normal saline administered by transcervical infusion 1 time on day of hCG trigger for ovulation 1 cm3 Only data from phase 1 were included (pre‐cross‐over), which were fresh transfers. |
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Outcomes | Clinical pregnancy rates, implantation rates, endometrial thickness | |
Notes | Trial was terminated prematurely. Data were available on trial registry site. Authors responded and provided clarification regarding study details. Study was not published. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Computer generated randomisation table with 50:50 distributions” |
Allocation concealment (selection bias) | Unclear risk | No information on method of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participant, care provider, investigator, outcome assessor were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant, care provider, investigator, outcome assessor were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants completed phase 1 of the trial. We only included data from phase 1 in the meta‐analysis (pre‐cross‐over). |
Selective reporting (reporting bias) | Low risk | Data for all prespecified outcomes were reported. |
Other bias | High risk | The trial was terminated prematurely before the calculated sample size could be achieved due to insufficient recruitment. The trial was not peer reviewed/published. |