An AI-based quantitative home-use framework for assessing fertility and identifying novel hormone trends by recording urine hormones

Fertility testing using urinary hormones has been used to improve the likelihood of pregnancy effectively. To provide fertility scores, the existing home-use systems measure one or two hormones. However, the hormone profiles vary depending on cycle duration, fertility-related disorders, drugs and other treatments. Here we introduce Inito, a mobile-phone connected reader that is scalable to multiple hormone tests. In this report, we assess the accuracy of the quantitative home-based fertility monitor, Inito Fertility Monitor (IFM), and suggest using IFM as a device to monitor and analyse female hormone patterns. We further show that Inito can be used as a tool to decipher novel hormone patterns in a more profound way than the existing knowledge in the field. There were two aspects to our analysis: i. Evaluation of Inito Fertility Monitor efficiency characteristics for urinary Estrone-3-glucuronide (E3G), Pregnanediol glucuronide (PdG) and Luteinizing hormone (LH) assessment, and ii. A retrospective study of patients' hormone profiles using IFM. For the performance assessment, the recovery percentage of the three hormones from IFM was evaluated using standard spiked solutions, the reproducibility of re-prediction and the correlation between re-predicted values from IFM and ELISA. The first urine sample of the day was collected from 100 women who volunteered for the study and IFM was provided to 52 more women to use it at home to track their fertile days. We observed that with all three hormones, IFM had an accurate recovery percentage and had a CV of less than 10 percent for separate test strips through tests of the same dosage making it a reliable tool to monitor hormone patterns of patients. Furthermore, in predicting the concentration of E3G, PdG and LH in urine samples, we show that IFM has a high correlation with ELISA. We show that certain hormone trends associated with urinary E3G, PdG and LH could be accurately captured using IFM. In addition, we report a novel criterion for earlier confirmation of ovulation compared to existing criteria. Finally, we present a novel hormone pattern associated with most of the menstrual cycles by examining hormone profiles from the volunteers recruited for the clinical trial. The Inito Fertility Monitor is an effective tool for calculating the urinary concentrations of E3G, PdG and LH and can also be used to provide accurate fertility scores and confirm ovulation. In addition, the sensitivity of IFM facilitates the monitoring of menstrual cycle-related hormone patterns, therefore also making it a great tool for physicians to track the hormones of their patients.

Descriptive Statistical Evaluation of the Standard Days Method of Family Planning

The Standard Days Method (SDM) is a method of family planning that assumes ovulation to be close to the midpoint of the menstrual cycle; fertility falls between days 8 and 19; and is most effective for cycle lengths between twenty-six and thirty-two days. The purpose of this study was to evaluate the assumptions of the SDM with a new data set of 714 menstrual cycles produced by 131 women (mean age twenty-nine) who tracked their fertility with an electronic fertility monitor that measured urinary estrogen and luteinizing hormone (LH). The LH peak was used to estimate the day of ovulation (EDO) and the six-day fertile window. Results indicated the majority (80 percent) of menstrual cycles had EDOs within three days of the midpoint of the cycle (86 percent with cycle lengths between twenty-six and thirty-two days). Approximately 22.5 percent (172) of the cycles had fertile window days outside of days 8 to 19, 10.2 percent (78) before, and 12.1 percent (92) after. However, there is a low probability of pregnancy when women experience short cycles and the early days of the fertile window are outside of days 8 through 19. We concluded assumptions of the SDM outside of the fertile window with long cycles could be problematic. However, the SDM is valid for women who have most cycles within the twenty-six to thirty-two day range.