Agarwal 2004.
Methods | Trial design: parallel Single centre, India | |
Participants | Couples with unexplained subfertility N randomised: IUI + OH 70; TI + OH 70 Age: IUI + OH 29.52 years (± 3.65); TI + OH 28.83 years (± 4.76) Duration of subfertility: IUI + OH 4.91 years (± 2.72); TI + OH 4.93 years (± 3.27) Basic fertility work‐up normal, semen normal according to WHO 1987 Previous treatment: no |
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Interventions | Comparison: IUI + OH versus TI + OH Stimulation method: 50 mg to 150 mg CC/day, day 3 to day 7 Ovulation: 10,000 IU hCG when not more than 4 follicles of > 16 mm were present Timing of IUI and TI: 36 hr to 40 hr after hCG Duration of treatment: 6 cycles max | |
Outcomes | Live birth and PR per couple and per cycle
Miscarriage rate
Ectopic PR
Multiple pregnancies Pregnancy confirmed by USS showing gestational sac |
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Notes | ITT analysis: possible Author provided additional information Unbalanced groups: dropouts 37% in IUI group, 1% in TI group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐number table |
Allocation concealment (selection bias) | Low risk | Adequate; sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not possible because of the nature of the interventions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding was not possible because of the nature of the interventions and non‐blinding was not likely to affect the outcomes of interest |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was an unequal dropout in the treatment group due to financial reasons; Nr of withdrawals: IUI + OH 26 (37%); TI + OH 1 (total 19%) |
Selective reporting (reporting bias) | Unclear risk | Reported on live birth, but authors provided additional information on ongoing pregnancies and twin pregnancies resulting in different data used for meta‐analysis |
Other bias | Low risk | Baseline demographic characteristics similar between the 2 groups |