From RCTs to RWE in ovarian stimulation: the latest French evidence comparing gonadotropins

Central to the lecture is the analysis of one of the largest national databases in France, which aggregates data on stimulation cycles across the whole country. This volume of observations makes it possible to compare the gonadotropins in use under conditions close to real practice and to assess outcomes in a sample no single randomised trial could reach.

The comparison of products is examined through the lens of both the biological differences between recombinant and urinary gonadotropins and the clinical outcomes of stimulation. The lecture discusses how the shift from RCT to RWE changes the interpretation of product comparability and which endpoints — from the number of oocytes retrieved to cumulative outcome measures — are most informative when assessed in a real-world population.

At the same time, the observational nature of RWE calls for cautious interpretation: without randomisation, comparisons between products are shaped by systematic differences between groups arising from clinician choice and patient characteristics. The lecture stresses that the value of large real-world datasets emerges only with sound statistical handling and awareness of potential bias, and that such data complement rather than replace the controlled experiment.

Particular attention is given to the economic dimension of gonadotropin choice. With constrained health-system resources and a growing volume of ART cycles, drug cost and cost-effectiveness become legitimate decision criteria alongside clinical performance. The lecture shows how real-world data allow the balance of cost and outcome to be assessed at a population level.

The practical takeaway is a methodological skill in critically appraising evidence. The clinician gains a framework for weighing RCT conclusions against observational data without treating either source as absolute, and for factoring the clinical and economic context into the choice of gonadotropin for an individual patient. This approach supports balanced decisions on the stimulation protocol grounded in the full body of available evidence.