Abstract
Previous systematic reviews comparing highly purified (HP) follicle-stimulating hormone (FSH) with recombinant (r) FSH in IVF/ICSI cycles have demonstrated conflicting results. This may be related to different patient populations, study quality and individual drugs compared. Meta-analysis of randomized trials comparing only currently available HP-FSH vs. rFSH. In order to assess the clinical profile and efficacy of these drugs meticulous computerized searches (last performed April 2007) were conducted. Furthermore, the reference lists of all known primary studies, review articles, citation lists of relevant publications, and included studies were examined to identify additional relevant citations. Finally, ongoing and unpublished trials were sought by contacting experts in the field and commercial entities. Primary outcome measures were the ongoing pregnancy/live birth rate and the rate of ovarian hyperstimulation syndrome. Secondary outcomes were the clinical pregnancy, multiple pregnancy and miscarriage rates, in addition to cycle characteristics (e.g. treatment duration, number of ampoules, E2 on day of HCG, number of oocytes retrieved). The primary outcomes, ongoing pregnancy/live-birth (O.R = 1.24, 95% CI = 0.76 to 2.01) and OHSS rates (O.R = 6.70, 95%CI = 0.4 to 7.17) were not significantly different between the two groups. As for the secondary outcomes, there was significantly less treatment days (WMD = −0.43, 95% CI = −0.72 to −0.14) and total dose of FSH (IU) (WMD = −1172.29, 95% CI = −1445.13 to −899.45) in the HP-FSH group compared with the rFSH group. Even so, the number of oocytes retrieved (WMD = −0.46, 95% CI = −1.05 to 0.13) was not significantly different between the two groups. In addition, there were no significant differences with regards the clinical pregnancy rate (O.R = 1.34, 95% CI = 0.96 to 1.88) or the other secondary outcomes. HP-FSH has been demonstrated to be non-inferior to rFSH with regards the clinical outcomes and patient safety. In addition it was shown to be superior in stimulation efficacy than rFSH, with less numbers of ampoules and treatment days needed to attain similar results.
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