van Rumste 2014.
Methods | Multi‐centre RCT | |
Participants | 116 couples with unexplained and mild male factor infertility. All couples had a standard fertility workup, including assessment of ovulation by basal temperature curve or ultrasound, a tubal patency test and sperm analysis. This study included all couples with unexplained or mild male subfertility, female age between 18 and 38 years and poor fertility prospects, defined as a 12‐month prognosis < 30% for natural conception according to the model of Hunault 2004 | |
Interventions | 1 cycle of IVF–eSET followed by 1 cryocycle or 3 cycles of IUI–ovarian stimulation. Results of freeze–thaw cycles were also included in this study, provided the transfer took place within 4 months after randomisation | |
Outcomes | Ongoing pregnancy rate per woman/couple, cost per cycle | |
Notes | Additional data on methods and outcomes were requested from lead author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central Internet‐based randomisation was stratified by centre |
Allocation concealment (selection bias) | Unclear risk | This was not mentioned |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | This was not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was performed |
Selective reporting (reporting bias) | Low risk | No other reports on the trial could be retrieved |
Other bias | Low risk | No other potential bias was noted |
Abbreviations:
AFS: American Fertility Society.
eSET: elective single embryo transfer.
FSH: follicle‐stimulating hormone.
ICSI: intracytoplasmic sperm injection.
IUI: intrauterine insemination.
IUI‐COH: intrauterine insemination‐controlled ovarian hyperstimulation.
IVF: in vitro fertilisation.
IVF‐SET: in vitro fertilisation‐single embryo transfer.
LBR: live birth rate.
SO: ovarian stimulation.