Introduction Across many fields of medicine, expensive technologies have often been widely adopted based solely on biological plausibility and surrogate outcomes rather than validated outcome benefits. In reproductive medicine, in vitro fertilization (IVF) likely exemplifies this pattern more than any other medical practice. This is because IVF features among the lowest expected outcome success rates in medicine. Therefore, marketable interventions that demonstrate potential efficacy are in high demand by physicians and patients alike. This commentary uses IVF as a case study to examine the “add-on phenotype” of contemporary medical innovation, exploring mechanisms that drive premature adoption of unvalidated technologies and outlining policy reforms to better align innovation with evidence, value, and equity. Current State of the Field Diagnostic and clinical add-ons have proliferated widely in routine IVF practice despite lacking any validation studies and, in some cases, despite showing strong evidence of no superiority or even inferiority. These add-ons include time-lapse incubation systems, preimplantation genetic testing for aneuploidy, routine blastocyst-stage culture, artificial intelligence-based embryo selection, and numerous additional unproven tests and clinical practices. Analysis The consequences of using these add-ons are serious. Despite the 2010 determination that chronological age is the primary predictor of IVF success, these add-ons have coincided with improvement failure or declining clinical pregnancy and live-birth rates in autologous fresh cycles nearly all around the world. This has occurred as treatment costs have steadily risen or skyrocketed in many countries, prompting governments and private insurers to provide less coverage and reduce access to treatment. Recommendations Current IVF practices are in need of radical reforms at multiple levels. Critical peer reviews of published papers are designed to remove business interests from the IVF literature. Enhanced post-marketing surveillance should provide much more transparent communications with patients about evidence quality and costs. Reimbursement policies should reward demonstrated value. These steps promote a professional culture that balances innovation with restraint. Conclusions IVF is not alone, with similar patterns of new expensive interventions reportedly being widely used in orthopedics, aesthetic medicine, and other medical specialties without robust demonstration of benefit. Addressing this issue requires minimum evidentiary standards, especially for non-life-saving technologies and treatments, in which such abuses are more common than in life-saving medicine, where effectiveness is immediately apparent. Paradoxically, IVF, with its clear outcome metric of live-birth rates, can pioneer such an improved model of clinical practice and, in this fashion, set new standards for evidence-based innovation.
Weissman et al. (Thu,) studied this question.