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. 2020 Mar 3;2020(3):CD001838. doi: 10.1002/14651858.CD001838.pub6

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
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
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