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)

Best Pract Res Clin Obstet Gynaecol. 2023 Jun:88:102308. doi: 10.1016/j.bpobgyn.2022.102308. Epub 2022 Dec 28.

Abstract

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.

Keywords: Cumulative live birth; France; HP-hMG; Live birth; Real-world data; r-hFSH.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Biosimilar Pharmaceuticals*
  • Female
  • Follicle Stimulating Hormone, Human* / administration & dosage
  • Gonadotropins
  • Humans
  • Ovulation Induction* / methods
  • Pregnancy
  • Reproductive Techniques, Assisted

Substances

  • Biosimilar Pharmaceuticals
  • Follicle Stimulating Hormone, Human
  • Gonadotropins