Shalev 1995.
| Methods | Trial design: parallel. Randomisation by self made computer program. Concealment of allocation by third party Blinding was used. Follow up: until birth characteristics were available. Power calculation for reduction in rate of OHSS was performed, but not further mentioned. ITT was not performed Study duration not stated |
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| Participants | 48 women, 140 cycles Inclusion criteria: anovulation, oligo‐ovulation or unexplained infertility Exclusion criteria: women at high risk of developing severe OHSS (> 20 mature pre‐ovulatory follicles and estradiol concentrations > 4000 pg/ml) Mean age of women: hCG group: 30.4 yrs and GnRH‐a group: 29.2 yrs Duration of subfertility: not stated per group, but at least one year Type of subfertility: anovulation, oligo‐ovulation or unexplained infertility |
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| Interventions | Stimulation method: individualized regime of HMG starting on cycle day five Intervention: 0.1 mg triptorelin or 10.000 IU hCG, IUI 24 and 48 hours after injection Type of semen injected: husband. Semen prepared by discontinuous Percoll gradient and washed twice. A volume of 0.3 to 0.5 ml of sperm suspension containing an average of 19 x 106 per ml of motile spermatozoa Insemination procedure: Tefcat catheter high in uterine cavity Number of inseminations: two |
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| Outcomes | Outcome live birth rate per cycle: 17.6% hCG group, 12.5% GnRH‐a group Pregnancy rate per cycle: 26.5% hCG group, 15.3% GnRH‐a group Pregnancy rate per couple: 45.8% hCG group, 66.7% GnRH‐a group Multiple pregnancy rate: 0% hCG group, 18% GnRH‐a group Miscarriage rate: 33.3% hCG group, 18% GnRH‐a group OHSS rate: 11.8% hCG group, 5.6% GnRH‐a group Ectopic pregnancy rate: not stated Costs: not stated Pregnancy diagnosed: rising concentration of hCG. Clinical pregnancy was diagnosed by fetal heart beat |
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| Notes | Very high pregnancy rate per couple Setting: Fertility Unit, Department of Obstetrics and Gynaecology, Central Emek Hospital, Afula, Israel No funding stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Author comment: randomisation was performed using a self made computer program. Adequate sequence generation not stated |
| Allocation concealment (selection bias) | Low risk | Author comment: third party |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding stated, but outcome not likely to be influenced either way |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding stated, but outcome not likely to be influenced either way |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Incomplete data adequately addressed |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No other bias |