OBJECTIVES: the aim of this analysis is to compare the effectiveness of recombinant FSH (rFSH) + recombinant LH (rLH) and human menopausal gonadotropin (hMG) controlled ovarian stimulation protocols in a well-defined subgroup of patients that underwent IVF in Italy.

METHODS: a probabilistic decision tree was developed to simulate the therapeutic path of a cohort of patients undergoing IVF, according to a rFSH + rLH or HMG controlled ovarian stimulation protocol. The model considers National Health System (NHS) perspective and a time horizon equal to two years with simulations of biannual cycles and a maximum of 3 therapy cycles. A one-way sensitivity analysis and a Probabilistic Sensitivity Analysis (PSA) were conducted to take into account the variability of the results based on the parameters considered in the analysis.

RESULTS: the model estimated that patients undertaking therapeutic protocol with rFSH + rLH, have advantages than the women undertaking a protocol with hMG, both in terms of waiting time (13.2 months vs 13.5 months for pregnancy and 7.2 months vs 7.5 months for the test positivity respectively) and in terms of general success rate (23.6% vs. 17.0% - P < 0.001 for pregnancy and 28.2% vs. 20.6% - P < 0.001 for positive tests respectively). The model estimated that, at the end of the analysed period, the ICER per QALY values are below a willingness to pay of €20 – €40,000. The simulations showed, for patients with ≥ 10 and ≤ 15 retrieved oocytes, that with a willingness to pay of €15,000/QALY the probability that rFSH + rLH therapeutic protocol is cost-effective respect to therapeutic protocol hMG is higher than 80%.

CONCLUSIONS: the cost-utility analysis demonstrated that the rFSH + hMG combination in controlled ovarian stimulation protocol in the IVF patients may be an opportunity from both economic and quality of life perspective.