Table 2 Summary of findings of phase 3 RCTs: follitropin delta compared to follitropin alfa/beta-
Outcomes | Anticipated absolute effects (95%CI) | Relative effect (95% CI) | Number of participants | Quality of the evidence (GRADE) | Comments | |
|---|---|---|---|---|---|---|
Risk with follitropin alfa/beta | Risk with follitropin delta | |||||
Duration of stimulation | The mean duration of stimulation in the control group ranged from 8.6 to 8.8 days | The duration of stimulation was longer in the group of women treated with follitropin delta compared to women treated with follitropin alfa/beta (MD 0.34, 95%CI: 0.14, 0.53; studies: 3) | // | 2682 | ⊕⊕⊕⊕ High | // |
Total dose of gonadotropin | The mean total dose of gonadotropin administered in the control group ranged from 103.7 to 149.9 µg | The total dose of gonadotropin administered was lower in the group of women treated with follitropin delta compared to women treated with follitropin alfa/beta (MD -37.07; 95%CI: -59.01, -15.13; studies: 3) | // | 2682 | ⊕⊕⊕⊝ Moderate1 | // |
Number of oocytes retrieved | The mean number of oocytes retrieved in the control group ranged from 10.4 to 12.4 oocytes | The mean number of oocytes retrieved was comparable between study groups (MD -1.32; 95%CI:-2.64, -0.00; studies: 3) | // | 2682 | ⊕⊕⊝⊝ Low1,2 | // |
Fertilization rate | The fertilization rate in the control group ranged from 56 to 64% | The fertilization rate did not differ between study groups (studies: 2) | // | // | ⊕⊝⊝⊝ Very low1,2,3 | Data of included studies could not be pooled because the denominator was not extractable |
Number of day 3 embryos | The mean number of day 3 embryos obtained in the control group ranged from 5.7 to 8.7 | The mean number of day 3 embryos obtained did not differ between study groups (studies: 2) | // | // | ⊕⊝⊝⊝ Very low1,2,3 | Data of included studies could not be pooled because the denominator was not extractable |
Number of blastocysts | The mean number of blastocysts obtained in the control group ranged from 3.5 to 4.2 | The mean number of blastocysts obtained did not differ between study groups (studies: 2) | // | // | ⊕⊝⊝⊝ Very low1,2,3 | Data of included studies could not be pooled because the denominator was not extractable |
CPR | 442 per 1348 (studies: 3) | 455 per 1334 (studies: 3) | OR 1.06; 95%CI: 0.90, 1.24 | 2682 | ⊕⊕⊕⊝ Moderate4 | // |
OPR | 373 per 1348 (studies: 3) | 400 per 1334 (studies: 3) | OR 1.15; 95%CI: 0.90, 1.46 | 2682 | ⊕⊕⊕⊝ Moderate4 | // |
LBR | 362 per 1348 (studies: 3) | 394 per 1334 (studies: 3) | OR 1.18; 95%CI: 0.89, 1.55 | 2682 | ⊕⊕⊝⊝ Low5 | // |
LBR at 4 weeks after birth | 327 per 1171 (studies: 2) | 354 per 1164 (studies: 2) | OR 1.15; 95%CI: 0.81, 1.63 | 2335 | ⊕⊕⊝⊝ Low5 | // |
Adoption of preventive strategies for OHSS | 87 per 1348 (studies: 3) | 41 per 1334 (studies: 3) | OR 0.45; 95%CI: 0.30, 0.66 | 2682 | ⊕⊕⊝⊝ Low5 | // |
Early OHSS | 86 per 1348 (studies: 3) | 54 per 1334 (studies: 3) | OR 0.46; 95%CI: 0.31, 0.67 | 2682 | ⊕⊕⊝⊝ Low5 | // |
All forms of OHSS | 100 per 1348 (studies: 3) | 62 per 1334 (studies: 3) | 0.61; 95%CI: 0.44, 0.84 | 2682 | ⊕⊕⊝⊝ Low5 | // |