Using Quantitative Hormonal Fertility Monitors to Evaluate the Luteal Phase: Proof of Concept Case Study.

Several new quantitative fertility monitors are now available for at-home use that measure estrogen, luteinizing hormone (LH), and progesterone (PDG) in urine. This case report compares the Mira and Inito quantitative fertility monitors with the well-established qualitative ClearBlue fertility monitor. Three clinical scenarios were evaluated: a normal cycle, a prolonged luteinization cycle, and an anovulatory cycle. The identification of the luteal phase (or lack thereof in the case of anovulation) and the transition through the three processes of luteinization, progestation, and luteolysis were clearly demarcated with the help of quantitative LH and PDG. Quantitative fertility monitors have the potential to identify details of the luteal phase to help women with regular cycles and abnormal luteal phases to help target interventions for optimizing fertility.

Improving usability and pregnancy rates of a fertility monitor by an additional mobile application: results of a retrospective efficacy study of Daysy and DaysyView app.

BACKGROUND: Daysy is a fertility monitor that uses the fertility awareness method by tracking and analyzing the individual menstrual cycle. In addition, Daysy can be connected to the application DaysyView to transfer stored personal data from Daysy to a smartphone or tablet (IOS, Android). This combination is interesting because as it is shown in various studies, the use of apps is increasing patients´ focus on their disease or their health behavior. The aim of this study was to investigate if by the additional use of an App and thereby improved usability of the medical device, it is possible to enhance the typical-use related as well as the method-related pregnancy rates. RESULT: In the resultant group of 125 women (2076 cycles in total), 2 women indicated that they had been unintentionally pregnant during the use of the device, giving a typical-use related Pearl-Index of 1.3. Counting only the pregnancies which occurred as a result of unprotected intercourse during the infertile (green) phase, we found 1 pregnancy, giving a method-related Pearl-Index of 0.6. Calculating the pregnancy rate resulting from continuous use and unprotected intercourse exclusively on green days, gives a perfect-use Pearl-Index of 0.8. CONCLUSION: It seems that combining a specific biosensor-embedded device (Daysy), which gives the method a very high repeatable accuracy, and a mobile application (DaysyView) which leads to higher user engagement, results in higher overall usability of the method.

Identification and prediction of the fertile window using NaturalCycles.

OBJECTIVES: The aim of the study was to evaluate the ability of a novel web and mobile application to identify a woman's ovulation day and fertile window, in order to use it as a method of natural birth control. METHODS: A retrospective study was performed on 1501 cycles of 317 women aged 18 to 39 years. Women entered their basal body temperatures, ovulation test results and date of menstruation into the application. RESULTS: The mean delay from the first positive ovulation test to the temperature-based estimation of the ovulation day was 1.9 days; the length of the luteal phase varied on average by 1.25 days per user. Only 0.05% of non-fertile days were falsely attributed and found within the fertile window. CONCLUSIONS: The method is effective at identifying a user's ovulation day and fertile window and can therefore be used as a natural method of birth control.

Predicting serum hormone concentration by estimation of urinary hormones through a home-use device.

STUDY QUESTION: Can a home-use device be used to predict serum hormone levels? SUMMARY ANSWER: A home-use device can predict urinary hormone values which are well-correlated to serum concentrations of respective hormones and hence can be used as a proxy for serum measurements. WHAT IS KNOWN ALREADY: Home-use devices that predict ovulation are calibrated against the actual day of ovulation. However, the correlation of any quantitative system to serum hormone concentrations has not been established. STUDY DESIGN SIZE DURATION: A total of 73 data points obtained from 20 participants across different phases of the menstrual cycle, i.e. bleeding days, follicular phase and luteal phase were used to establish the correlation between serum hormones and urinary metabolite values. Single data points from 20 random users were used to assess the correlation established. PARTICIPANTS/MATERIALS SETTING METHODS: Participants were women in the fertile age groups and only current users of the home-use device. Selection was done based on inclusion and exclusion criteria. Blood hormones were tested using chemiluminescent immunoassays and urinary measurements were taken on the home-use device at home. MAIN RESULTS AND THE ROLE OF CHANCE: Serum estradiol (E2), progesterone (P4) and LH were correlated with urinary estrone-3-glucuronide (E3G), pregnanediol glucuronide (PdG) and LH with an R 2 of 0.96, 0.95 and 0.98, respectively. Repredicted serum concentration obtained by using the correlation equation had a correlation of 0.92, 0.94 and 0.93 in unknown samples. LIMITATIONS REASONS FOR CAUTION: The study was designed to include women who have normal cycle lengths regularly; therefore, the values obtained were in the normal range. Certain infertility conditions may cause the values to be higher and correlation in such cases needs to be established. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study imply a new tool that can be used by fertility specialists as a proxy for blood tests whenever required. Extended study on this system can enable its use in assisted reproductive techniques as well. STUDY FUNDING/COMPETING INTERESTS: No funding was received for this study. S.P. and D.D. are employees of the research and development division of Samplytics Technologies Pvt. Ltd. which is a forwarder for Inito Inc., USA. A.R. and V.A.V. are co-founders of Inito Inc., USA. TRIAL REGISTRATION NUMBER: The trial was registered at the International Standard Randomised Controlled Trial Number (ISRCTN) registry (Identifier: ISRCTN15534557).

A pilot study comparing the DuoFertility(®) monitor with ultrasound in infertile women.

BACKGROUND: The purpose of this study was to assess the accuracy of ovulation detection by the DuoFertility(®) monitor compared with transvaginal ultrasound in infertile women with regular menstrual cycles. METHODS: Eight infertile patients, aged 27-40 years, with a body mass index of 19-29, regular menses, normal ovaries on pelvic ultrasound scan, and normal early follicular luteinizing hormone (LH), follicle-stimulating hormone, and prolactin were recruited from infertility clinics in primary and secondary care for this pilot, prospective, observational study. The patients were asked to use the DuoFertility monitor for the whole cycle, with investigators and patients blind to DuoFertility data. Daily urine LH monitoring commenced on cycle day 8, with daily transvaginal ultrasound following the first positive LH until ovulation was observed. Ovulation was further confirmed by serum progesterone. The main outcome measure was detection of ovulation by the DuoFertility monitor, and correlation between day of ovulation assessed by DuoFertility and ultrasound. RESULTS: DuoFertility identified ovulation as having occurred within one day of that determined via ultrasound in all cycles. The sensitivity of ovulation detection was 100% (95% confidence interval 82-100). The specificity could not be concluded from the data. CONCLUSION: In infertile women with regular cycles, the DuoFertility monitor appears to accurately identify ovulatory cycles and the day of ovulation.