Sakhel 2007.

Methods	Single centre, parallel. Randomly assigned by computer generated numbers, sealed envelopes Blinding not stated. Follow up: not clearly stated. Power calculation: performed afterwards, a power of 63% was achieved. ITT was not performed since no dropouts or cycle cancellations were reported Duration: April 2003 to March 2004
Participants	284 women, 284 cycles Inclusion criteria: healthy women between 22 and 44 years with non‐tubal infertility. One fallopian tube should be patent, unexplained subfertility, ovulatory disorder, mild to moderate male factor, early stages of endometriosis and advanced stages of endometriosis after conservative operative laparoscopy Exclusion criteria: tubal blockage and severe male factor Mean age of women: r‐hCG group: 31.9 ± 4.1 yrs and u‐hCG group: 32.7 ± 4.8 yrs Duration of subfertility: r‐hCG group: 2.3 ± 1.5 yrs and u‐hCG group: 3.0 ± 2.3 yrs Type of subfertility: ovulatory disorders, early stage endometriosis, mild male factor, idiopathic infertility. Primary infertility in 55.8% of couples
Interventions	Stimulation method: 75 to 150 IU FSH and HMG, GnRH antagonist IUI 42 hours after injection of 10,000 IU u‐hCG or 250 µg r‐hCG Type of semen injected: husband. Semen washed using the double‐density gradient method. Insemination of 0.3 ml Insemination procedure: not stated, one insemination
Outcomes	Outcome live birth rate per couple: 22.1% r‐hCG, 25% u‐hCG Pregnancy rate per couple: 27.1% r‐HCG, 28.5% u‐hCG Multiple pregnancy rate per cycle: 36.8% r‐hCG, 36.6% u‐hCG Miscarriage rate per cycle: 10.5% r‐hCG, 4.9% u‐hCG OHSS rate: no cases of severe OHSS Ectopic pregnancy rate per cycle: 7.9% r‐hCG, 7.3% u‐hCG Costs: not stated Pregnancy diagnosed: serum hCG level two weeks after the insemination
Notes	Aggressive stimulation with a mean number of ovulated follicles of 2.3 ± 1.4 r‐hCG group and 3.0 ± 2.0 u‐hCG group, resulting in a high pregnancy and multiple pregnancy rate Setting: IVF Michigan PC, Rochester Hills, MI, USA Funding: supported in part by Serono, Rockland, Massachusetts
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly assigned by computer generated numbers
Allocation concealment (selection bias)	Unclear risk	None stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No blinding, but outcome not likely to be influenced
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No blinding, but outcome not likely to be influenced
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	High risk	Comment: the included women in the u‐hCG group had a greater mean duration of infertility than the r‐hCG group