Owen 1991.
Methods | Randomisation: Two randomisation lists were made with 20 women on each list and block randomised into blocks of four. Allocation Concealment: method unclear Blinding: double‐blind Trial design: Parallel. Analysis: No power calculation or intention to treat analysis performed. Study setting: single centre, location London. Withdrawals: none (<10%). Cancelled Cycles: <10%. | |
Participants | Number of women:n= 25 (13 growth hormone, 12 placebo). Inclusion criteria: one or more previous IVF cycles with poor response, defined as fewer than six oocytes retrieved from which fewer than three embryos developed. Cause of subfertility: 18 of 25 women found to have polycystic ovaries on ultrasound. Age: <38 |
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Interventions | Intervention: growth hormone 24 IU intramuscular (IM), days 1, 3, 5, 7, 9, and 11 of hMG treatment, during long GnRHa protocol, vs placebo given IM on same cycle days as active treatment groups. Dose of human chorionic gonadotropin: 5000 IU | |
Outcomes | Live birth rate, pregnancy rate, adverse effects (multiple pregnancy and ectopic pregnancy). | |
Notes | Nature of placebo not described. Follicular fluid IG1 increased by 27% with growth hormone treatment. The data from Jacobs 1995 is also presented in Owen 1991. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Two randomisation lists were made with 20 women on each list and block randomised into blocks of four |
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 | Nature of placebo not described. Follicular fluid IG1 increased by 27% with growth hormone treatment |