Summary of findings 1. G‐CSF compared to no treatment or placebo in subfertile women undergoing assisted reproduction.
| G‐CSF compared to no treatment or placebo in subfertile women undergoing assisted reproduction | ||||||
| Patient or population: subfertile women undergoing assisted reproduction Setting: private clinic or academic setting Intervention: G‐CSF Comparison: no treatment or placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with no treatment or placebo in subfertile women undergoing assisted reproduction | Risk with G‐CSF | |||||
| Ongoing pregnancy rate per woman randomised |
162 per 1000 | 263 per 1000 (139 to 499) | RR 1.62 (0.86 to 3.08) | 150 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | |
| Miscarriage rate per woman randomised | 35 per 1000 | 14 per 1000 (3 to 61) | Peto OR 0.40 (0.09 to 1.77) | 291 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 3 4 | |
| Clinical pregnancy rate per woman randomised |
178 per 1000 | 294 per 1000 (235 to 367) | RR 1.65 (1.32 to 2.06) | 1050 (12 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 5 6 | |
| Clinical pregnancy rate ‐ unselected or unstated IVF number |
232 per 1000 | 260 per 1000 (174 to 390) | RR 1.12 (0.75 to 1.68) | 291 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 3 | |
| Clinical pregnancy rate ‐ 2 or more IVF failures | 148 per 1000 | 312 per 1000 (227 to 429) | RR 2.10 (1.53 to 2.89) | 553 (6 RCTs) | ⊕⊕⊝⊝ LOW 2 7 | |
| Clinical pregnancy rate ‐ women with thin endometrium | 184 per 1000 | 291 per 1000 (175 to 485) | RR 1.58 (0.95 to 2.63) | 206 (4 RCTs) |
⊕⊕⊝⊝ LOW 2 8 | |
| Multiple pregnancy rate | None of the included trials reported multiple pregnancy rate as an outcome. | |||||
| Adverse events per woman randomised | 0 per 1000 | 0 per 1000 (0 to 0) |
Not estimable | 410 (4 RCTs) |
‐ | None of the 4 trials reported any major adverse effect. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; G‐CSF: granulocyte‐colony stimulating factor; IVF: in vitro fertilisation; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Very serious indirectness, downgraded by two levels: only one study reported ongoing pregnancy rate and the study included only unselected population, limiting applicability of results to the other subpopulations. 2Serious imprecision, downgraded by one level due to wide confidence interval and low number of events. 3Serious risk of bias, downgraded by one level: one study had low risk of bias for all domains. One study was at high risk of reporting bias. 4Serious indirectness, downgraded by one level: only two studies reported miscarriage rates, and both the studies included an unselected IVF population. The reported miscarriages in the studies only captured first trimester losses. 5Serious risk of bias, downgraded by one level: only two studies were at low risk of bias for all domains. Most of the remaining studies were at high risk of performance bias and unclear risk of bias for allocation concealment. There is a likelihood of overestimation of the treatment effect. 6 Serious inconsistency, downgraded by two levels: there was substantial variability between effect estimates between the two subgroups, P = 0.06. 7Serious risk of bias, downgraded by one level: only one study was at low risk of bias for all domains. Most of the remaining studies were at high risk of performance bias and unclear risk of bias for allocation concealment. There is a likelihood of overestimation of the treatment effect. 8Serious risk of bias, downgraded by one level: three studies were at unclear risk of bias for allocation concealment. Two studies were at high risk of other potential sources of bias. There is a likelihood of overestimation of the treatment effect.