Ovulation Double Check® Prototype Results
In October 2016 we produced and shipped 1st generation prototypes to home users. Based off their feedback, we changed several aspects of the test to improve its quality. First generation tests were in bulky packaging and constructed of materials that fell apart easily. Most importantly, the threshold was too high since only 59% of users reported that they could get a positive result.
In December 2016 we produced and shipped 2nd generation prototypes to home users. Packaging, test construction, and threshold were changed. The new tests not only looked better, but performed much better. 92% of the users were able to observe a positive result. Below is a summary of our results from the 2 sets of prototypes.
How we conducted our research studies
Home users were provided Ovulation Double Check® tests and asked to report their test results back to MFB Fertility. Users tracked ovulation via clinical signs such as cervical mucus, urine LH surge, and/or Clearblue Fertility Monitor. Users would self-report when they believed "peak" fertility had occurred. Ovulation Double Check® tests were taken both before and after "peak" fertility was detected. No users reported a positive Ovulation Double Check® test result before "peak" fertility. Only 59% of first generation users reported seeing a positive Ovulation Double Check® test result after "peak" fertility was determined. 92% of second generation test users reported seeing a positive test result with the average time to positive being 3-5 days post "peak" fertility.
Ovulation confirmation was done via serum progesterone testing under the care of a medical doctor. Patients were monitored via urine LH surge. Prior to LH surge, Ovulation Double Check® tests were negative. 6 days after LH surge blood progesterone levels were >6-8ng/ml and Ovulation Double Check® tests were positive.
Several more clinical studies are planned for 2017. We look forward to collecting more data and improving the test as needed. New results will be posted here when available.
Recent studies show that a positive Ovulation Double Check test result occurs when serum (blood) progesterone levels are >6-8ng/ml
Typical users see Ovulation Check Check tests turn positive 4-6 days after positive OPK (LH surge). By 6 days after LH surge, 92.3% of users were seeing positive test results.