Andrés‐Oros 2008.
| Methods | Single centre, parallel prospective randomised trial. Computer generated list of random numbers. Concealment of allocation: third party Blinding not stated. Follow up not stated. Duration study not stated Power calculation not stated |
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| Participants | 120 couples, 290 cycles, at least 2 years of subfertility Exclusion criteria: women with PCOS or other cycle disturbances, semen analysis < 5 million after work up Mean age of women: r‐hCG group: 32.2 yrs ± 2.5 and GnRH‐a group: 32.3 yrs ± 2.5 Type of subfertility: unexplained, endometriosis stage 1 or 2, male factor (WHO 1992), unilateral tubal factor |
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| Interventions | GnRH‐a versus r‐hCG for triggering ovulation in IUI Stimulation method: 75 IU FSH, 250 ug r‐hCG sc or 0.2 mg GnRH‐a sc (triptorelin 0.2 mg) IUI 36 hours after injection of hCG or GnRH‐a Type of semen not explicitly stated. Semen prepared with a swim up technique Insemination procedure: Gynetics catheter, one insemination per cycle |
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| Outcomes | Clinical pregnancy rate per couple: r‐hCG group 21/60 (35%), GnRH‐a group 15/42 (35.7%) Number of miscarriages: r‐hCG group 3/21 (14%), GnRH‐a group 1/15 (6.7%) Multiple pregnancy rates: r‐hCG group 0/21 (0%), GnRH‐a group 1/15 (6.7%) Pregnancy diagnosed: transvaginal ultrasound demonstrating heart activity |
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| Notes | 60 couples received r‐hCG and only 42 couples received GnRH‐a. The other 18 couples did not reach the point to induce ovulation due to too many, or no follicles. The author did not have an explanation for this difference Setting: Assisted Reproduction Service. Miguel Servet University Hospital, Zaragoza, Spain No funding |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer generated list of random numbers |
| Allocation concealment (selection bias) | Unclear risk | None stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding stated, outcome not likely to be influenced |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding stated, outcome not likely to be influenced |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No other bias |