Suikkari 1996 12 IU.
| Methods | Randomisation: Stated as randomised. Allocation concealment: unclear. Blinding: Double blind. Trial Design: Parallel. Analysis: No power calculation and no intention to treat analysis performed Study Setting: two centres. Analysis: No power calculation or intention to treat analysis performed. Withdrawals: Withdrawals: < 10% . Cancelled Cycles: >10% (therefore include in meta‐analysis but perform sensitivity analysis). |
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| Participants | Number of women : n=22 (10 growth hormone four IU, six growth hormone 12 IU, six placebo) Inclusion Criteria: previous poor response in more than or equal to two assisted cycles. Definition of poor Response: < or equal to two oocytes retrieved or > or equal to 48 AMP hMG consumed in a stimulation cycle. Cause of subfertility: tubal (n=10), endometriosis (n=1), male factor (n=2), idiopathic (n=9). Age 25‐40 years. | |
| Interventions | Intervention: six women received 12 IU growth hormone and 10 women received 4 IU growth hormone daily SC from day three of spontaneous menstrual cycle. Study Protocol: A boost "flare‐up" protocol was used for ovarian stimulation. On day two of spontaneous menstrual cycle leuprolide acetate was administered SC 0.75mg in the morning. On day three gonadotrophin Metrodin was started at 300IU SC for four days then adjusted according to serum E2 and follicular growth. Dose of human chorionic gonadotropin 5000 IU IM given when the largest follicle(s) reached a diameter of 18 to 20mm. | |
| Outcomes | Live birth rate, pregnancy rate, embryo transfer and adverse effects (multiple pregnancy). | |
| Notes | Same trial as Suikkari 1996 but refers to women randomised to growth hormone 12 IU treatment arm. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Stated as randomised |
| Allocation concealment? | Unclear risk | Not stated within the text |
| Blinding? All outcomes | Low risk | Double blinded |
| Free of selective reporting? | Low risk | There is no indication the study has reported outcomes selectively |
| Free of other bias? | High risk | Cancelled Cycles: >10% (therefore include in meta‐analysis but perform sensitivity analysis) |