Why Clinical Evidence Matters In Fertility Tech – And Beyond
The digital transformation of the fertility space has brought us everything from period tracking apps to FDA-cleared digital contraceptives. Yet these tools are often grouped together under broad categories that obscure critical differences in their purpose and effectiveness. The reality is that ‘fertility tech’ encompasses many different products with different uses and aims. It’s crucial to understand these distinctions and how they relate to regulation, clinical data and science-backed evidence.
The spectrum of fertility awareness-based methods
Fertility awareness-based methods (FABMs) have existed for decades - the rhythm method being perhaps the most well-known historical example. These methods involve tracking signs of fertility to predict ovulation and identify the fertile window. Today's digital versions range from simple calendar-based calculators to sophisticated algorithms analysing multiple physiological parameters.
However, FABMs used for contraception have fundamentally different uses than general period-tracking apps. A general tracking app can be helpful in giving women a good idea of when their most fertile time is likely to be. If there is a lack of accuracy, the consequence could be no conception. But when a product claims to prevent pregnancy by identifying fertile days — so you know which days to use protection, or abstain from sex — accuracy is essential, as the consequence of inaccurate readings could be unwanted pregnancy.
This distinction is why regulation and proper clinical evidence is rightly required for digital contraceptives. And it works. Natural Cycles, for example, is a FDA-cleared class II medical device, and is 93% effective with typical use and 98% effective with perfect use. Its effectiveness and safety has been demonstrated across 10 peer-reviewed clinical studies, including one of the largest analyses of its kind.
Products like Natural Cycles are not comparable with period-tracking apps, which help users pinpoint fertile periods, but also anticipate their periods, prepare with products, plan schedules around their cycles, optimize workout routines etc. These tools enhance wellbeing and body literacy but make no claims about preventing pregnancy. As such, they sit in the wellness category and understandably don't require the same level of science-backed evidence, or regulatory oversight.
Yet the lines between these two product categories are often blurred, meaning there is confusion over what needs to be regulated in the fertility tech space and what doesn’t. In short, if your product makes a claim to prevent pregnancy, then it must have undergone a rigorous process of clinical trials to provide proper science-backed evidence for its effectiveness, so women have access to digital contraception that’s proven to work. The required evidence is often built through layers of validation. For example, the product must first demonstrate accuracy against clinical gold standards. Then, the algorithm interpreting that data needs to be benchmarked against established clinical measures, and finally, real-world studies confirm whether users achieve the intended outcomes.
The evidence gap across women's health
This situation reflects a challenge in women's health: the persistent lack of clinical evidence across the board. Despite women making up 51% of the population, research in women's health remains underfunded and understudied. Shamefully, women were excluded from clinical trials until 1993. So, we’re playing catch up in a landscape that is dominated by data based on male physiology. This means vast knowledge gaps exist, from how medications affect women differently to fundamental misunderstandings about conditions that predominantly and disproportionately affect them.
Also, women wait longer for diagnoses, have their symptoms more frequently dismissed as ‘normal’ or attributed to ‘stress’ or ‘hormones’, and spend a greater proportion of their lives in ill health compared to men. Research funding for women's health remains disproportionately low, and even when studies include women, findings are rarely disaggregated by sex — missing crucial opportunities to understand how conditions manifest differently.
The path forward requires the same scientific rigor that has long been applied to other areas of medicine. This means we need reliable data derived from comprehensive female-only clinical trials that include women across all life stages and health conditions, real-world evidence that captures diverse experiences, and regulatory frameworks that demand the same standards of proof whether a product serves men or women. Only through this commitment to evidence-based development can we begin to close the knowledge gaps that have left half the population underserved.
Disclosure: The author serves on the Medical Expert Committee at Natural Cycles.
At Lindus Health, we help women’s health innovators design and deliver clinical trials that close evidence gaps and generate the high-quality, real-world data needed to bring proven, science-backed products to market faster. Learn more about our work.
