Recombinant FSH vs. Other Gonadotropins: A Meta-Analysis Compares Efficacy and Safety in IVF/ICSI Ovarian Stimulation

Ovarian stimulation is a critical step in in vitro fertilization (IVF) and intra-cytoplasmic sperm injection (ICSI), aiming to produce multiple follicles for aspiration. Current standard-of-care involves gonadotropin administration, but various types exist, including recombinant and urinary forms. The choice of gonadotropin can impact efficacy, safety, and cost, making direct comparisons essential for optimizing patient outcomes. This review addresses the need for a comprehensive, updated assessment of recombinant follicle-stimulating hormone (rFSH) against other established and emerging gonadotropin preparations.

This review update systematically analyzed all randomised controlled trials comparing recombinant follicle-stimulating hormone (rFSH) with other gonadotropins for ovarian stimulation in women undergoing IVF or ICSI. An extensive search was conducted on March 31, 2025, across the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, and Embase. Eligible studies compared rFSH against human menopausal gonadotropin (HMG), highly purified HMG (HP-HMG), purified urinary FSH (FSH-P), highly purified urinary FSH (FSH-HP), follitropin delta, and rFSH biosimilars. The primary outcomes assessed were live birth, ovarian hyperstimulation syndrome (OHSS), and clinical pregnancy, adhering to the core outcome set for infertility. The Trustworthiness in RAndomised Controlled Trials (TRACT) checklist was used to assess study quality, with problematic studies excluded.

This comprehensive review update aims to establish the comparative effectiveness and safety of recombinant follicle-stimulating hormone (rFSH) across a spectrum of alternative gonadotropin preparations. The primary objective is to compare rFSH against three main categories: urinary gonadotropins (including HMG, HP-HMG, FSH-P, and FSH-HP), rFSH derived from a human cell line (follitropin delta), and various rFSH biosimilars. The critical outcomes under evaluation are live birth, ovarian hyperstimulation syndrome (OHSS), and clinical pregnancy rates in women undergoing IVF or ICSI treatment cycles. While the abstract details the rigorous methodology and scope, it does not present the synthesized numerical results or specific statistical comparisons from the meta-analysis. > The review's core focus is to provide a robust evidence base for clinicians on whether rFSH offers superior, equivalent, or inferior outcomes compared to other gonadotropins regarding key efficacy and safety endpoints.