A Comparison of Two Hormonal Fertility Monitoring Systems for Ovulation Detection: A Pilot Study.

Background and Objectives: Accuracy in detecting ovulation and estimating the fertile window in the menstrual cycle is essential for women to avoid or achieve pregnancy. There has been a rapid growth in fertility apps and home ovulation testing kits in recent years. Nevertheless, there lacks information on how well these apps perform in helping users understand their fertility in the menstrual cycle. This pilot study aimed to evaluate and compare the beginning, peak, and length of the fertile window as determined by a new luteinizing hormone (LH) fertility tracking app with the Clearblue Fertility Monitor (CBFM). Materials and Methods: A total of 30 women were randomized into either a quantitative Premom or a qualitative Easy@Home (EAH) LH testing system. The results of the two testing systems were compared with the results from the CBFM over three menstrual cycles of use. Potential LH levels for estimating the beginning of the fertile window were calculated along with user acceptability and satisfaction. Results: The estimates of peak fertility by the Premom and EAH LH testing were highly correlated with the CBFM peak results (R = 0.99, p < 0.001). The participants had higher satisfaction and ease-of-use ratings with the CBFM compared to the Premom and EAH LH testing systems. LH 95% confidence levels for estimating the beginning of the fertile window were provided for both the Premom and EAH LH testing results. Conclusions: Our pilot study findings suggest that the Premom and EAH LH fertility testing app can accurately detect impending ovulation for women and are easy to use at home. However, successful utilization of these low-cost LH testing tools and apps for fertility self-monitoring and family planning needs further evaluation with a large and more diverse population.

[Fertility Awareness Based Methods]. / Natürliche Familienplanung.

Fertility Awareness Based Methods Abstract. The so called natural family planning methods are based on the prospective detection of the few fertile days (fertile window) during the menstrual cycle. The existence of such a fertile window was originally based on observation of the menstrual cycle which showed that that the lowest fertlity was at the beginning and in the seccond half of the cycle. On this observation the calendar method was based. Later other signs of ovulation were detected (temperature, cervical mucus and even later the LH peak) which allowed to better predict the fertile phase. It became evident that the contraceptive efficacy was dependent on the number of ovulation related variables and the continuity and regularity of the measurements (user adherence). The new data collecting technologies facilitate correct and regular data collection and may such offer new opportunities.

Soft Candy as an Electronic Material Suitable for Salivary Conductivity-Based Medical Diagnostics in Resource-Scarce Clinical Settings.

Soft candy was discovered to be an excellent electronic material and was used to fabricate electrodes for salivary conductivity-based diagnostics. Using a simple molding process, a soft candy (Tootsie Roll) was made into 20 × 20 × 5 mm electrodes with a stable frequency response (0.1-100 kHz). The soft candy electrode-liquid interface circuit model was also developed for the first time. Using 0.01, 0.05, and 0.1 M phosphate-buffered saline and artificial saliva of varying conductivities, the performance of the soft candy (Tootsie Roll) electrode was evaluated. The electrode has a low temperature coefficient of ∼0.02 V/C, and the evaporation-induced mass change during measurement (<3 min) was negligible. Using a trenched surface, a limit of detection (LOD) of ∼1630 µS/cm was obtained and was lower than the saliva conductivity of a healthy adult at ∼3500 µS/cm. Thus, it is suitable for monitoring the ovulation cycle for natural family planning as well as chronic kidney disease diagnosis. Given the ubiquity of soft candy, the simplicity of the molding process, and the negligible medical waste stream, it is a more appropriate approach to diagnostics design for resource-scarce clinical settings, such as those in developing countries. The broader impact of this work will be the paradigm shift of soft candy from food to a new class of edible, moldable, high-resistivity, and stable electronic materials.

Direct measurement of pregnanediol 3-glucuronide (PDG) in dried urine spots by liquid chromatography-mass spectrometry to detect ovulation.

BACKGROUND: Non-invasive self-testing using an objective chemical method to detect ovulation is valuable for women planning conception, practising contraception or undergoing infertility investigations or treatment. METHODS: Based on luteal phase secretion of progesterone (P4) and excretion of its major metabolite, pregnanediol glucuronide (PDG), we developed a novel direct liquid chromatography-mass spectrometry (LCMS) method to measure PDG and other steroid glucuronides in urine and in dried urine spots (DUS) without deconjugation or derivatization. Urine PDG by LCMS and immunoassay (P3G) and P4 by immunoassay with and without adjustment for creatinine were evaluated in daily first void urine samples from 10 women through a single menstrual cycle in which ovulation was confirmed by serial transvaginal ultrasound. RESULTS: Urine PDG with and without creatinine adjustment was stable during the follicular phase with the expected striking rise in the luteal phase peaking at 5 days after ovulation. Using a single spot urine sample (100 µL) or a DUS (<20 µL urine) and an optimal threshold to distinguish pre- from post-ovulatory samples, in ROC analysis urine PDG adjusted for creatinine accurately identified ovulation in 92 % of samples was comparable with P3G immunoassay and superior to urine P4 with or without adjustment for creatinine. Extending the analysis to two or three consecutive daily samples reduced the false negative rate from 8% to 2.6 % for two and 1.9 % for three urine samples. CONCLUSIONS: This method holds promise as a non-invasive self-test method for women to determine by an objective chemical method their ovulatory status.

Fertility Awareness-Based Methods for Family Planning: A Literature Review.

A review of 23 research articles to examine fertility awareness-based methods revealed biologic indicators and tracking methods to identify the fertile window in reproductive-aged women. This literature review indicated that a woman's cycle regularity is a major determinant of which method is best. Additionally, the woman's desire to achieve a pregnancy and her preference regarding the intensity of training are factors in method choice. Some evidence suggests that use of at least two biologic indicators is most effective for determining the fertility window. Recommended web and mobile applications also are discussed.

Modulation of saliva pattern and accurate detection of ovulation using an electrolyte pre-deposition-based method: a pilot study.

We developed an electrolyte pre-deposition-based saliva pattern modulation method to detect ovulation with high accuracy and reliability. Ovulation tests using human saliva have advantages in terms of the earlier ovulation detection and more convenient sample collection procedure; however, accuracy is low, which is a critical limitation given that the concentrations of salivary constituents can vary depending on the health status of the tested individual and subjective user judgement of the test result. In this study, we quantitatively analyzed saliva patterns according to the concentrations of electrolytes and proteins in the ovulation test and found that changes in the saliva pattern during the ovulatory period can be controlled by sodium chloride (NaCl) pre-deposition, which directly affects the accuracy of ovulation detection. The 100 nmol NaCl pre-deposition condition proved optimal, being two-fold more sensitive to changes in saliva pattern versus the non-pre-deposition condition (accuracy of ovulation detection = 66.6% and 33.3%, respectively). Although accuracy remained insufficient for actual applications compared to the urine-based ovulation detection method, we expect that the electrolyte pre-deposition method will greatly contribute to enhancing the performance of saliva-based ovulation detection tests, toward a commercially satisfactory level of accuracy.

Increased Likelihood of Pregnancy Using an App-Connected Ovulation Test System: A Randomized Controlled Trial.

Background: Women trying to conceive are increasingly using fertility-tracking software applications to time intercourse. This study evaluated the difference in conception rates between women trying to conceive using an application-connected ovulation test system, which measures urinary luteinizing hormone and an estrogen metabolite, versus those trying without using ovulation testing. Materials and Methods: This home-based study involved 844 volunteers aged 18-40 years seeking to conceive. Volunteers randomized to the test arm were required to use the test system for the duration of the study while those randomized to the control arm were instructed not to use ovulation testing. Pregnancy rate differences across one and two cycles between the two groups were examined. Results: Volunteers in the test (n = 382) and control arms (n = 403) had similar baseline demographics. The proportion of women pregnant after one cycle was significantly greater in the test arm (25.4%) compared with the control arm (14.7%; p < 0.001). After two cycles, there continued to be a greater proportion of women pregnant in the test arm compared with the control arm (36.2% vs. 28.6%; p = 0.026). In the test arm, volunteers had intercourse less frequently per cycle compared with those not using ovulation testing (9 [range: 1-60] vs. 10 [range: 1-50]; p = 0.027), but were more likely to target intercourse to a particular part of their cycle compared with those not using ovulation testing (88.5% vs. 57.8%; p < 0.001). Conclusion: Using the test system to time intercourse within the fertile window increases the likelihood of conceiving within two menstrual cycles.

Detection and Prediction of Ovulation From Body Temperature Measured by an In-Ear Wearable Thermometer.

OBJECTIVE: We present a non-invasive wearable device for fertility monitoring and propose an effective and flexible statistical learning algorithm to detect and predict ovulation using data captured by this device. METHODS: The system consists of an earpiece, which measures the ear canal temperature every 5 min during night sleep hours, and a base station that transmits data to a smartphone application for analysis. We establish a data-cleaning protocol for data preprocessing and then fit a Hidden Markov Model (HMM) with two hidden states of high and low temperature to identify the more probable state of each time point via the predicted probabilities. Finally, a post-processing procedure is developed to incorporate biorhythm information to form a time-course biphasic profile for each subject. RESULTS: The performance of the proposed algorithms applied to data collected by the device are compared with traditional methods in terms of match rate with self-reported ovulation days confirmed with an ovulation test kit. Empirical study results from a group of 34 users yielded significant improvements over the traditional methods in terms of detection accuracy (with sensitivity 92.31%) and prediction power (23.07-31.55% higher). CONCLUSION: We demonstrated the feasibility for reliable ovulation detection and prediction with high-frequency temperature data collected by a non-invasive wearable device. SIGNIFICANCE: Traditional fertility monitoring methods are often either inaccurate or inconvenient. The wearable device and learning algorithm presented in this paper provide a user friendly and reliable platform for tracking ovulation, which may have a broad impact on both fertility research and real-world family planning.

Advantages of determining the fertile window with the individualised Natural Cycles algorithm over calendar-based methods.

Purpose: This study aims to compare the accuracy of fertile window identification with the contraceptive app Natural Cycles against the Rhythm Method and Standard Days Method (SDM).Materials and methods: Menstruation dates, basal body temperature (BBT), and luteinising hormone (LH) test results were collected anonymously from Natural Cycles app users. The fraction of green days (GDs) and wrong green days (WGDs) allocated by the various algorithms was determined over 12 cycles. For comparison of Natural Cycles and the Rhythm Method, 26,626 cycles were analysed.Results: Natural Cycles' algorithms allocated 59% GDs (LH, BBT) in cycle 12, while the fraction of WGDs averaged 0.08%. The Rhythm Method requires monitoring of six cycles, resulting in no GDs or WGDs in cycle 1-6. In cycle 7, 49% GDs and 0.26% WGDs were allocated. GDs and WGDs decreased to 43% and 0.08% in cycle 12. The probabilities of WGDs on the day before ovulation with Natural Cycles were 0.31% (BBT) and 0% (LH, BBT), and 0.80% with the Rhythm Method. The probability of WGDs on the day before ovulation was 6.90% with the SDM.Conclusions: This study highlights that individualised algorithms are advantageous for accurate determination of the fertile window and that static algorithms are more likely to fail during the most fertile days.

Comparison of progesterone assay by chemiluminescence or radioimmunoassay for clinical decision-making in canine reproduction.

The Coat-A-Count® radioimmunoassay has been long and widely used to determine the concentration of progesterone in serum or plasma of bitches (progRIA), but was discontinued in 2014. The Immulite® 1000 LKPG1 chemiluminescence immunoassay has gained prominence since 2003 to determine the concentration of progesterone in serum of bitches, but the assay changed in 2012 (Immulite® 1000 LKPW1). This study assessed the feasibility of using Immulite® 1000 LKPW1 (progImm) to estimate the time of clinically relevant events during oestrus and compared progRIA and progImm 2 and 3 days after the first or only day of the luteinizing hormone surge (LH1). ProgImm first exceeded 5.1 nmol/L on the same day that progRIA first exceeded 6 nmol/L, a proxy for the occurrence of the LH surge, or the day before in 28 of 31 (90%) of oestrous periods. ProgImm first exceeded 13.6 nmol/L on the same day that progRIA first exceeded 16 nmol/L (a proxy for the day of ovulation) or the day before in 34 of 35 (97%) oestrous periods. ProgImm first exceeded 5.4 nmol/L on LH1 or the day before in 24 of 25 (95%) of oestrous periods. The median of progImm 2 days after LH1 was 1.2 nmol/L lower than the 10.7 nmol/L of progRIA (p = 0.001). The mean of progImm 3 days after LH1 was 2.2 nmol/L lower than the 19.0 nmol/L of progRIA (p 0.001). In conclusion, the days on which progImm first exceeded 5.1 nmol/L, 13.6 nmol/L and 5.4 nmol/L effectively estimate the days on which progRIA reached 6 nmol/L or 16 nmol/L or LH1.

Findings from a mobile application-based cohort are consistent with established knowledge of the menstrual cycle, fertile window, and conception.

OBJECTIVE: To investigate the validity of self-reported fertility data generated by a mobile application-based cohort in comparison with data collected by traditional clinical methodologies. DESIGN: Data were collected from July 2013 to July 2018 through a mobile application designed to track fertility. Bayesian hierarchical models were used to assess day-specific pregnancy probabilities. Descriptive statistics were used to estimate differences in day of ovulation and lengths of menstrual phases and to assess changes in the cervix and ovulation-related symptoms drawing closer to the day of ovulation. SETTING: Not applicable. PATIENT(S): Data consisted of 225,596 menstrual cycles from 98,903 women. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Day-specific probabilities of pregnancy, variability in lengths of the follicular and luteal phases, trends in prevalence of symptoms and cervix changes across the fertile window. RESULT(S): Analyses were consistent with established clinical knowledge. Probability of conception was highest during the 5 days before and day of ovulation, with the highest probability occurring the day before ovulation. The average cycle length was 29.6 days, and average lengths of the follicular and luteal phases were 15.8 and 13.7 days, respectively. Closer to day of ovulation, women were more likely to report changes in the cervix corresponding to fluid consistency, feel, position, and openness and symptoms associated with ovulation, including pelvic pain, tender breasts, increased sex drive, and cramps. CONCLUSION(S): Components of the menstrual cycle and fertile window, when re-evaluated with a mobile application-based cohort, were found to be consistent with established clinical knowledge, suggesting an agreement between traditional and modern data collection methodologies.

An objective volumetric method for assessment of ovarian follicular and luteal vascular flow using colour Doppler ultrasonography.

Our goal was to develop an objective computer-assisted volumetric method of assessing vascular flow from colour Doppler ultrasound data of ovarian structures recorded by free-hand movement. We hypothesized that a vascularity index (ratio of the region of blood flood to the region of ovarian structure) obtained from the three-dimensional volumetric analysis would be more precise (less variable) than conventional two-dimensional analysis of single images in estimating the functional status of the preovulatory follicles and corpus luteum. Doppler ultrasound cineloops of water buffaloes (Bubalus bubalis; n = 22) ovaries were recorded daily from 12 h before GnRH treatment to four days after ovulation. Cineloops were processed using Fiji and Imaris software packages for segmenting the area (two-dimensional analysis) and the volume (three-dimensional analysis) occupied by the blood-flow and associated tissue to calculate the vascularity index. For volumetric measurement, all images in a cineloop were used (i.e., no a-priori selection of images) while for two-dimensional analysis, three images from the region with apparent maximum vascularity were selected. The volumetric method was verified with theoretical ellipsoidal volume of the follicle (r = 0.96 P < 0.01) or corpus luteum (r = 0.58 P = 0.02). The variability in the follicular vascularity index among animals was lower using the volumetric method than two-dimensional analysis (0.018 ±â€¯0.002 vs 0.030 ±â€¯0.005, P < 0.01), while the variability for CL vascularity was similar between methods (P = 0.23). An increase in the follicular vascularity index was detected at 12 h after GnRH treatment using both methods (two-dimensional: 0.030 ±â€¯0.008, P < 0.01; three-dimensional: 0.016 ±â€¯0.006, P < 0.02). Buffaloes that ovulated tended to have a greater increase in 3D vascularity index than non-responding buffaloes (P = 0.06); the two-dimensional method was not able to detect these changes. Using the three-dimensional method, a moderate positive correlation (r = 0.59; P = 0.02) was evident between the follicular vascularity index at 14-16 h after GnRH treatment and follicular diameter. In conclusion, an objective volumetric method for assessing relative ovarian blood flow changes was developed using Doppler ultrasound cineloops recorded by free-hand movement. The 3-dimensional method eliminates the need for a-priori selection of images and is more precise as a result of decreased technical variability.

Menstrual cyclicity is predictably unpredictable.

"Time moves slowly but passes quickly" - Alice Walker.

A novel high-throughput assay for the measurement of salivary progesterone by liquid chromatography tandem mass spectrometry.

BACKGROUND: Liquid chromatography tandem mass spectrometry (LC-MS/MS) enables specific and sensitive quantification of steroids with a high throughput. Saliva sampling is advantageous for multisample profiling over longer periods of time, as it is non-invasive, cheap, can be carried out at home and does not require the attendance of clinical personnel. We developed a rapid LC-MS/MS for the measurement of salivary progesterone, frequently assessed as ovulation marker in patients desiring fertility. METHODS: Samples (300 µL) were prepared by supported liquid extraction using dichloromethane and were reconstituted in 40% methanol. Chromatography was performed using a C8 column with a water/methanol gradient containing 0.1% formic acid and 2 mmol/L ammonium acetate. Quantification was performed with a Waters TQ-S mass spectrometer. RESULTS: Total run time was 5.5 min. The lower limit of quantification was 20 pmol/L (1.2 fmol on column). Inter- and intra-assay comparison showed coefficients of variation and bias between measured and nominal concentrations of less than 11%. Mean recovery was 91%. Interference with a large set of natural and synthetic steroids was excluded. The assay was successfully applied to measure progesterone variation during the menstrual cycle ( n = 9) and diurnal variations during luteal phase ( n = 7) in regularly cycling women. DISCUSSION: We present a novel LC-MS/MS assay for the determination of salivary progesterone with high-throughput potential. The applicability of the assay for progesterone profiling during the menstrual cycle is demonstrated.

An inexpensive smartphone-based device for point-of-care ovulation testing.

The ability to accurately predict ovulation at-home using low-cost point-of-care diagnostics can be of significant help for couples who prefer natural family planning. Detecting ovulation-specific hormones in urine samples and monitoring basal body temperature are the current commonly home-based methods used for ovulation detection; however, these methods, relatively, are expensive for prolonged use and the results are difficult to comprehend. Here, we report a smartphone-based point-of-care device for automated ovulation testing using artificial intelligence (AI) by detecting fern patterns in a small volume (<100 µL) of saliva that is air-dried on a microfluidic device. We evaluated the performance of the device using artificial saliva and human saliva samples and observed that the device showed >99% accuracy in effectively predicting ovulation.

[Natural Family Planning methods and Barrier: CNGOF Contraception Guidelines]. / Méthodes de contraception naturelle et méthodes barrières. RPC contraception CNGOF.

OBJECTIVE: To develop clinical practice recommendations for the use of natural contraception and female and male barrier methods. MATERIALS AND METHODS: A systematic review of English and French literatures related to the safety and effectiveness of natural contraceptive methods based on PubMed, Cochrane Library, practice recommendations issued by international scientific societies and guidelines provided by the World Health Organization (WHO) as well as updates from the Center for Disease Control and Prevention (CDC). RESULTS: Natural contraceptives methods include fertility awareness-based methods, lactational amenorrhea method (LAM) and withdrawal method. The prevalence is low (4.6% of users) and remains stable over the years. Identification of the fertile period can be symptom-based cervical mucus (Billings), two-day method, basal body temperature, symptom-thermal method or based on calendar calculation (Ogino-Knauss, standard day method). Pregnancy rate after one-year utilization varies from 0.4% to 5% in perfect use but 8% in common practice. Effectiveness increases with absence of vaginal sex and decreases when combined to barriers method inadequately implemented. Data is scarce on reliability and effectiveness of ovulation predictor kits readily available on internet. Lactational amenorrhea method (LAM) can be very effective (98%) provided three conditions are fulfilled: within 6 months after birth, amenorrhea is effective, and breastfeeding is exclusive or quasi exclusive (day/night). Withdrawal method is constraining and of limited effectiveness. Male and female condom, diaphragm, cervical cap and spermicides are mechanical and chemical barrier methods, preventing spermatozoids from passing through the cervix into the uterus and therefore preventing fecundation. Female and male condoms offer a double protection to avoid pregnancy and prevent STD's. They are effective provided strict conditions of use are fulfilled. Male condom is favored by teenagers (45.6% among 15 to 19 years old), sometimes in combination with contraceptive pill (16% of cases). Women on the pill decreases according to their age. Pregnancy rates within the first year of consistent and correct use of these methods vary between 5 to 26% and reach 20 to 32% in practical use. Diaphragm and cervical cap need to be used in combination with spermicides. Spermicides have limited effectiveness when used alone. CONCLUSION: In common practice, natural and barrier contraceptive methods are more constraining and less effective than modern contraceptive method. They can be an alternative at given time and/or in situations where the women or the couple accept the possibility of an unexpected pregnancy which might be terminated or not. Women/couples need to be properly informed on how to use such methods, on their disadvantages and possible failures in common practice. Reminders are to be given on emergency contraceptive methods (IUD, hormonal) after unprotected sex.

Canine ovulation timing: A survey on methodology and an assessment on reliability of vaginal cytology.

Ovulation timing in bitches is a routine procedure in small animal practice around the world. It is most frequently used for supporting breeding management, high-risk pregnancy monitoring and determination of the time of parturition. To learn more about how and for what reasons veterinarians interested in small animal reproduction perform canine ovulation timing, an online survey was conducted in 2017. The link to the survey was distributed via the mailing list cafereprod-l@list.cornell.edu and the website, the Twitter account and the Facebook page of EVSSAR. All respondents recommended using quantitative progesterone measurement for ovulation timing alone or in combination with other diagnostic tests. Vaginal cytology was also a commonly used technique. The 63 respondents followed different protocols for sampling and staining vaginal epithelial cells. Interestingly, 50 respondents used vaginal cytology routinely, but only two consider it as a very reliable and another nine as a somewhat reliable test if used alone. In a second project, delegates attending the EVSSAR congress held in Vienna, Austria, in June 2017 had the opportunity to examine seven stained vaginal smear slides under optical microscopy in a blinded approach. The results showed a marked heterogeneity in the identification of vaginal cells and assessment of the time in relation to ovulation. This heterogeneity supports the opinion of survey participants that vaginal cytology alone is not a valid tool for determining the day of ovulation. Results of both projects suggest that there is no standard procedure for the examination of vaginal smears in dogs. It is not recommended to determine the optimal time for mating based on the examination of a single vaginal smear only. According to some comments of survey participants, it is more useful to assess vaginal samples repeatedly and to use the findings to determine when to start progesterone measurement.

Menstrual Patterns in the First Gynecological Year: A Systematic Review.

STUDY OBJECTIVE: Understanding what constitutes a normal menstrual cycle during the first gynecological year (GY1) is a common concern of adolescents and clinicians. However, limited high-quality evidence exists. We aimed to summarize published literature regarding menstrual and ovulatory patterns in GY1. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: Electronic databases (MEDLINE, Pre-MEDLINE, Embase, Web of Science, CINAHL, Cochrane Library) were systematically searched from database inception to 2018. Eligible studies described menstrual cycles, symptoms, or validated ovulatory data in healthy adolescents in GY1. Two authors independently screened studies, extracted data, and assessed methodological quality. RESULTS: Twenty-two studies involving more than 2000 adolescents were included. Thirteen recorded menstrual cycle and/or symptom data and 14 measured ovulation. Mean cycle length ranged from 32 to 61 days and decreased throughout GY1. Mean menses length was 4.9 to 5.4 days. Frequent menstrual bleeding was reported in up to 23% of participants, infrequent menstrual bleeding in up to one-third, and "irregular menstrual bleeding" in up to 43%. Dysmenorrhea was reported by 30%-89% of participants. Prevalence of ovulatory cycles identified using luteal phase serum or salivary progesterone or urinary pregnanediol was 0 to 45% and increased throughout GY1. However, all used definitions that would be considered subovulatory in clinical practice. CONCLUSION: Menstrual and ovulatory patterns in GY1 are diverse and differ from those of adults. A transitional phase of menstrual and ovulatory immaturity is common. However, ovulation, irregular cycles, and dysmenorrhea are not uncommon. As such, safe sexual practice should be advocated and prompt medical management should be accessible.

Published analysis of contraceptive effectiveness of Daysy and DaysyView app is fatally flawed.

BACKGROUND: In March 2018, Dr. Martin C. Koch and colleagues published an analysis purporting to measure the effectiveness of the Daysy device and DaysyView app for the prevention of unintended pregnancy. Unfortunately, the analysis was flawed in multiple ways which render the estimates unreliable. Unreliable estimates of contraceptive effectiveness can endanger public health. MAIN BODY: This commentary details multiple concerns pertaining to the collection and analysis of data in Koch et al. 2018. A key concern pertains to the inappropriate exclusion of all women with fewer than 13 cycles of use from the Pearl Index calculations, which has no basis in standard effectiveness calculations. Multiple additional methodological concerns, as well as prior attempts to directly convey concerns to the manufacturer regarding marketing materials based on prior inaccurate analyses, are also discussed. CONCLUSION: The Koch et al. 2018 publication produced unreliable estimates of contraceptive effectiveness for the Daysy device and DaysyView app, which are likely substantially higher than the actual contraceptive effectiveness of the device and app. Those estimates are being used in marketing materials which may inappropriately inflate consumer confidence and leave consumers more vulnerable than expected to the risk of unintended pregnancy. Prior attempts to directly convey concerns to the manufacturer of this device were unsuccessful in preventing publication of subsequent inaccurate analyses. To protect public health, concerns with this analysis should be documented in the published literature, the Koch et al. 2018 analysis should be retracted, and marketing materials on contraceptive effectiveness should be subjected to appropriate oversight.