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. 2020 Jan 24;2020(1):CD013226. doi: 10.1002/14651858.CD013226.pub2

NCT01202643.

Study characteristics
Methods RCT
Single centre
USA
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:
  • Sickle cell disease

  • Renal insufficiency

  • Upper respiratory infection or pneumonia

  • Chronic neutropenia

  • Known past or present malignancy

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.
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 The trial was not peer reviewed/published.