Comparative effectiveness of gonadotropins used for ovarian stimulation during assisted reproductive technologies (ART) in France: A real-world observational study from the French nationwide claims database (SNDS)

This comparative non-interventional study using data from the French National Health Database (Système National des Données de Santé) investigated real-world (cumulative) live birth outcomes following ovarian stimulation, leading to oocyte pickup with either originator recombinant human follicle-stimulating hormone (r-hFSH) products (alfa or beta), r-hFSH alfa biosimilars, or urinaries including mainly HP-hMG (menotropins), and marginally u-hFSH-HP (urofollitropin). Using data from 245,534 stimulations (153,600 women), biosimilars resulted in a 19% lower live birth (adjusted odds ratio (OR) 0.81, 95% confidence interval (CI) 0.76–0.86) and a 14% lower cumulative live birth (adjusted hazard ratio (HR) 0.86, 95% CI 0.82–0.89); and urinaries resulted in a 7% lower live birth (adjusted OR 0.93, 95% CI 0.90–0.96) and an 11% lower cumulative live birth (adjusted HR 0.89, 95% CI 0.87–0.91) versus originator r-hFSH alfa. Results were consistent across strata (age and ART strategy), sensitivity analysis using propensity score matching, and with r-hFSH alfa and beta as the reference group. [Display omitted] •This is the first study to assess the effectiveness of gonadotropins in France, in a nationwide claims database.•Treatment with biosimilars resulted in a 19% lower LBR (adjusted OR 0.81, 95% CI 0.76–0.86) vs. originator r-hFSH alfa.•Treatment with biosimilars resulted in a 14% lower CLBR (adjusted HR 0.86, 95% CI 0.82–0.89) vs. originator r-hFSH alfa.•Treatment with urinaries (mainly HP-hMG) resulted in a 7% lower LBR (adjusted OR 0.93, 95% CI 0.90–0.96) vs. r-hFSH alfa.•Treatment with urinaries (mainly HP-hMG) resulted in a 11% lower CLBR (adjusted HR 0.89, 95% CI 0.87–0.91) vs. originator r-hFSH alfa.