Are all human-derived follicle-stimulating hormone products the same? A systematic review and meta-analysis using direct and adjusted indirect analyses, to determine whether Fostimon^® is more efficient than Metrodin-HP^®

Abstract

Background. Randomized trials (RCTs) and systematic reviews have challenged the claim for superiority of recombinant follicle-stimulating hormone (recFSH) compared with human-derived FSH (hFSH). Even so, much of the evidence comes from unavailable products. If the efficacy of the currently available Fostimon^® is superior, the off-market Metrodin-HP^®, then data from the latter should not be used, gauge of the former.

Methods. Electronic/hand searches were performed to identify RCTs comparing Fostimon^® vs. Metrodin-HP^® or either product with recFSH. Primary outcomes were live-birth rate (LBR), ongoing pregnancy rate (OPR), and OPR/LBR. Secondary outcomes were clinical pregnancy rate (CPR), multiple pregnancy rate (MPR), ovarian hyperstimulation syndrome (OHSS), abortion rates, and cycle demographics. Data were extracted, allowed for an intention-to-treat analysis, and meta-analyzed using combined direct/adjusted indirect methods.

Results. Twenty-two RCTs met the inclusion criteria: Fostimon^® vs. Metrodin-HP^® (n = 2); Fostimon^® vs. recFSH (n = 8); and Metrodin-HP^® vs. recFSH (n = 12). LBR (odds ratio = 1.72; 95% confidence interval = 1.05–2.80), OPR/LBR, and CPR were all significantly higher favoring Fostimon^®. OPR, MPR, OHSS, and miscarriage rates were not significantly different. Pooled results for cycle demographics were not reported due to high heterogeneity.

Conclusions. Fostimon^® is superior to Metrodin-HP^® regarding clinical outcomes. Therefore, care should be taken not to assume that all hFSH products have the same efficacy.

Keywords:

• hFSH
• recombinant FSH
• Fostimon^®
• Metrodin-HP^®
• meta-analysis

Acknowledgements

The authors kindly acknowledge IBSA International for the financial support of this study. There was no influence from the sponsors on the outcomes of this study.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.