Goldman 2014.
| Methods | Randomised controlled parallel trial, with clinicians blinded to outcome determinations. Intention‐to‐treat analysis performed, numbers of and reasons for withdrawals and dropouts stated, clearly defined interventions applied with standardised protocols, couples followed up until discharge from the hospital of both mother and infant(s), if pregnant, or 1 year after completion of treatment protocol. Tables with permuted blocks of varying sizes, stratified by the woman's age (38th to 41st vs 42nd to 43rd birthday) | |
| Participants | 154 couples Inclusion criteria Couples in which the woman had 38 to 42 years 6 months of attempted conception; at least 1 ovary and ipsilateral patent fallopian tube confirmed by hysterosalpingogram or laparoscopy; regular menstrual cycles of 21 to 45 days; and no pelvic pathology, ectopic pregnancy nor previous infertility treatment (except up to 3 cycles of clomiphene without IUI). Normal prolactin and thyroid‐stimulating hormone levels and body mass index (BMI) < 38 in the woman; sperm concentration > 15 million total motile sperm or > 5 million total motile sperm at reflex IUI preparation in the male partner Exclusion criteria Age outside the range, prior infertility treatment or not a candidate for study treatments, or not covered by a participating insurer |
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| Interventions | Three‐arm randomised controlled trial. Couples were randomly assigned to treatment with 2 cycles of clomiphene citrate (CC) and intrauterine insemination (IUI), follicle‐stimulating hormone (FSH)/IUI or immediate IVF, followed by by 3 cycles of IVF if not pregnant | |
| Outcomes | Live birth, clinical pregnancy, multiple pregnancy and time to conception were reported | |
| Notes | Population of the study consisted of women with relatively advanced reproductive age | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The allocation sequence was generated by an independent biostatistician", using tables with permuted blocks of varying sizes, stratified by the woman's age (38th to 41st vs 42nd to 43rd birthday) |
| Allocation concealment (selection bias) | Low risk | Remote allocation: "The allocation sequence was ... implemented by an epidemiologist. Randomization was never conducted by clinical staff" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | All clinical investigators were blinded to outcome determinations |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 154/154 randomly assigned women were included in the ITT analysis |
| Selective reporting (reporting bias) | Low risk | Live birth, clinical pregnancy, multiple pregnancy and time to conception were reported |
| Other bias | Low risk | No other potential bias could be observed |