Ovia Health’s clinical research team regularly conducts research to identify ways to improve women’s health and the healthcare experience. It’s critical to us that the research we conduct is not only evidence-based and clinically valid, but that it is also subjected to the same rigorous processes and standards that academic research is subject to.
One of the remarkable things about our clinical research is the reach we have. Traditional women’s health research typically amasses only a couple hundred participants, and draws conclusions from these relatively small samples. Ovia Health is able to conduct peer-reviewed, academic research with samples 1000x the size of those used in traditional research studies.
With digital technologies still gaining traction and to some extent still being viewed as untested, Ovia Health’s clinical research team wanted to ensure that our digital data collection methodologies were validated in peer-reviewed literature and on par with traditional data collection methodologies like biospecimen sampling.
To test this, our clinical team conducted a study that mirrored a landmark 1995 study by Wilcox et al. Wilcox’s groundbreaking research was published in the New England Journal of Medicine (NEJM) and helped to identify define the fertile window as the day of ovulation and the 5 days preceding it. Their sample size was 221 women who were planning to become pregnant. They asked each woman to keep a written diary of intercourse and to provide daily urine samples (used to identify the day of ovulation).
Since then, countless works have been published based on this definition of the fertile window. However, Wilcox's work has never been replicated because it is incredibly time consuming and expensive to ask hundreds of women to provide daily urine samples.
Ovia Health, however, had the ability to replicate this study. Using data from nearly 99,000 women — amounting to more than a quarter of a million menstrual cycles — Ovia’s clinical research team replicated Wilcox's work and tested whether these findings from more than two decades ago still hold up.
Our team found that they do.
The results from our study were just published in the industry-leading publication Fertility and Sterility. The results found mirrored Wilcox’s findings, including daily probability of conception, relative to the fertile window. Our research also examined symptoms known to be associated with ovulation (e.g., cramping, cervical mucus consistency, etc.) and the results were consistent with current clinical understand. The main difference between our paper and Wilcox’s paper was which day of the fertile window has the highest probability of conception. According to Wilcox’s data, it's the day of ovulation itself. According to Ovia’s data, it's the day prior to ovulation. There have been countless papers for the last few decades arguing one day or the other, but none with a sample of this size.
What does this mean? This means that research that leverages digital methods of collecting data are just as accurate as traditional methods, and because digital methods allow researchers to have larger sample sizes, the data found from research conducted this way contributes important new information to women’s health literature. This will impact women’s health research for years to come, and will help researchers study and improve women’s health on a much larger scale.
To read more about this research, click here.