Comparison of efficacy, safety, and economy of recombinant and urinary follicle-stimulating hormone in women with a predicted normal response undergoing assisted reproductive technology.

Abstract

Background: The administration of exogenous gonadotropins (Gn) to elicit multi-follicular development for controlled ovarian stimulation (COS) represents a pivotal component of assisted reproductive technology (ART). Presently, the exogenous Gn preparations most frequently utilized are recombinant follicle-stimulating hormone (rFSH) and urinary follicle-stimulating hormone (uFSH). Given the contentious results from previous studies, it is imperative to conduct a comprehensive assessment of their efficacy, safety, and economy.

Methods: A retrospective cohort study was conducted from January 2017 to December 2021, encompassing 3,966 women with a predicted normal response who underwent ART treatment. These patients were stratified into two groups based on the type of exogenous Gn administered: the rFSH group (N = 1,785) and the uFSH group (N = 2,181). Propensity score matching (PSM) and Cox proportional hazards model were utilized to control potential confounders. The primary evaluation indicators for efficacy, safety, and economy were the cumulative delivery rate (CDR) per initiated cycle, the incidence of moderate-to-severe ovarian hyperstimulation syndrome (OHSS), and the cost of controlled ovarian stimulation (COS), respectively. After matching all baseline characteristics, each group retained 1,133 cycles, with the baseline characteristics between the two groups being comparable.

Results: Our results showed that the uFSH group exhibited a higher Gn starting dose, total Gn dose, and a longer stimulation duration compared to the rFSH group after PSM. Conversely, the rFSH group had a higher number of ≧ 14 mm follicles on trigger day, oocytes retrieved, and transferable embryos. There were no significant differences in the live birth rate for both fresh embryo transfer (50.3% vs. 51.7%) and frozen embryo transfer (44.2% vs. 42.5%) between rFSH and uFSH group. CDR were also comparable (56.1% vs. 55.0%), with an adjusted hazard ratio of 0.98 (95% confidence interval: 0.88-1.09). The incidence of moderate-to-severe OHSS was also similar in both groups (1.0% vs. 0.6%). However, the rFSH group incurred significantly higher costs of COS (RMB, 8947.6 ± 1888.0 vs. 5958.0 ± 1057.4; P < 0.001).

Conclusions: In women with a predicted normal response undergoing ART treatment, rFSH and uFSH result in similar CDR and incidence of moderate-to-severe OHSS. However, the rFSH leads to a higher cost of COS.