Wirleitner 2015b.
Methods | Design: 2‐arm parallel RCT | |
Participants |
Number: 480 Women's age (mean years; experimental vs control): 40.3 vs 40.4 Inclusion criteria: women aged 38 to 43 years Exclusion criteria: recurrent implantation failure Ovarian controlled hyperstimulation: GnRH agonist long protocol Fertilisation: IMSI Stage of the embryo at transfer: blastocyst Embryo processing: fresh Number of embryos transferred: 1 or 2 |
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Interventions |
Experimental (n = 255): intrauterine hCG 500 IU dissolved in 40 μL embryo culture medium administered 3 minutes before ET Control (n = 225): administration of 40 μL culture medium without hCG 3 minutes before ET |
|
Outcomes | Clinical pregnancy, miscarriage, live birth | |
Notes |
Location: IVF‐Centers Prof. Zech, Bregenz, Austria Period: not mentioned Power calculation: yes Funding: funded by hospital/clinic(s) ‐ this study was not externally funded Trial registration: CRT 355 Publication type: abstract |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was mentioned without further details. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not blinded, but unlikely to induce bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were followed up. |
Selective reporting (reporting bias) | Low risk | Reports on all relevant outcomes |
Other bias | Low risk | Baseline characteristics of participants were comparable between 2 study groups. |