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

Pattnaik, S. B.; Das, Dipankar; Venkatesan, Varun Akur; Rai, Aayush

doi:10.1093/hropen/hoac058

Cited by 8 publications

(6 citation statements)

References 19 publications

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“…In addition, a recent study published in 2023 compared E2, progesterone and LH concentrations to E3G, PdG and LH in urine. A correlation of 0.96, 0.95 and 0.98 allowed researchers to conclude that the use of urine tests instead of blood is acceptable whenever testing is required [14]. These results indicate that LFAs are accurate alternatives to blood sampling that are more convenient, painless, eliminate the need for venipuncture, and can be completed at home on a regular basis.…”

Section: Lateral Flow Immunoassays' Performancementioning

confidence: 89%

Gonadotropin and Ovarian Hormone Monitoring: Lateral Flow Assays for Clinical Decision Making

Targonskaya,

Maslowski

2023

Women

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FSH, estrogen and progesterone testing are widely utilized in clinical practice. Lateral flow assays (LFAs) are cost-effective tools used for diagnosing infectious diseases, pregnancy, and substance testing. The focus of this narrative review is the potential for the wider utilization of listed hormone LFAs. A search was conducted with PubMed, Google Scholar and Wiley online libraries using keywords without any limitation on the publication date; animal studies were excluded. Clinical guidelines for the related conditions were included. According to published data, E3G and PdG are used to determine ovulatory cycles and can be utilized for research purposes to establish the normal range of menstrual cycles, as there is currently disagreement among guidelines. FSH measurement in blood samples is utilized to predict oocyte yield in assisted cycles and to differentiate women with premature ovarian insufficiency from hypothalamic amenorrhea, and can be replaced with more convenient urine testing. PdG was tested to assess the risk of pregnancy complications, specifically miscarriage and ectopic pregnancy, and might become a screening tool for miscarriage in the future. PMS, PMDD and ovarian carcinogenesis could be extensively studied using LFAs to gain a better understanding of the biology behind these conditions. Before implementing these LFAs into clinical practice, the reproducibility of progesterone assays should be evaluated. The results are critical for treatment decisions, and universally recognized standards for estradiol measurement should be developed.

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Section: Lateral Flow Immunoassays' Performancementioning

confidence: 89%

Gonadotropin and Ovarian Hormone Monitoring: Lateral Flow Assays for Clinical Decision Making

Targonskaya,

Maslowski

2023

Women

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“…Prior research has demonstrated that many period tracker apps provide conflicting information on an ovulation day and a fertile window [ 4 , 6 , 26 ]. Several consumer-available tracking technologies are in the early stages of reliability testing for tracking or confirming ovulation [ 7 , 13 , 27 , 28 ]. More research is needed to validate their use for family planning.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to smartphone apps and temperature tracking devices, there has been significant growth in the development of at-home urine hormone testing devices that can measure multiple reproductive hormone levels across the menstrual cycle. Direct-to-consumer urine hormone testing devices include, but are not limited to, the Clearblue ® Fertility Monitor [ 11 ], Proov ® [ 12 ], Inito Fertility Monitor [ 13 ], Mira ® Fertility Tracker [ 14 ], and Oova™ Fertility Tracker [ 15 ]. Prior to these technologies, it was neither feasible nor cost-effective to measure hormone levels at multiple timepoints throughout the menstrual cycle.…”

Section: Introductionmentioning

confidence: 99%

Survey Analysis of Quantitative and Qualitative Menstrual Cycle Tracking Technologies

Stujenske,

Mu,

Pérez Capotosto

et al. 2023

Medicina

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Background and Objectives: Digital health and personalized medicine are advancing at an unprecedented pace. Users can document their menstrual cycle data in a variety of ways, including smartphone applications (apps), temperature tracking devices, and at-home urine hormone tests. Understanding the needs and goals of women using menstrual cycle tracking technologies is the first step to making these technologies more evidence based. The purpose of this study was to examine the current use of these technologies and explore how they are being used within the context of common hormonal and reproductive disorders, like polycystic ovary syndrome (PCOS), endometriosis, and infertility. Materials and Methods: This was a cross-sectional study evaluating menstrual cycle tracking technology use. Participants were recruited in January–March 2023 using social media groups and a Marquette Method instructor email listserv. Data were collected using an electronic survey with Qualtrics. Data collected included participant demographics, menstrual cycle characteristics, reproductive health history, and menstrual cycle tracking behavior. Results: Three-hundred and sixty-eight participants were included in the analysis. Women had various motivations for tracking their menstrual cycles. Most participants (72.8%) selected “to avoid getting pregnant” as the primary motivation. Three hundred and fifty-six participants (96.7%) reported using a fertility awareness-based method to track and interpret their menstrual cycle data. The Marquette Method, which utilizes urine hormone tracking, was the most frequently used method (n = 274, 68.2%). The most frequently used cycle technology was a urine hormone test or monitor (n = 299, 81.3%), followed by a smartphone app (n = 253, 68.8%), and a temperature tracking device (n = 116, 31.5%). Women with PCOS (63.6%), endometriosis (61.8%), and infertility (75%) in our study reported that the use of tracking technologies aided in the diagnosis. Most participants (87.2%) reported a high degree of satisfaction with their use and that they contributed to their reproductive health knowledge (73.9%). Conclusions: Women in our study reported avoiding pregnancy as their primary motivation for using menstrual cycle tracking technologies, with the most frequently used being a urine hormone test or monitor. Our study results emphasize the need to validate these technologies to support their use for family planning. Given that most women in this study reported using a fertility awareness-based method, the results cannot be generalized to all users of menstrual cycle tracking technologies.

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“…IFM uses a multi-scale algorithm to detect the device and eliminate the variations in resolution and aspect ratio due to smartphone variability 11 . A recent study has also shown that urine metabolite measurements by IFM are well correlated with their respective serum hormones 30 .…”

Section: Introductionmentioning

confidence: 90%

Validation of urinary reproductive hormone measurements using a novel smartphone connected reader

Pattnaik¹,

Das²,

Venkatesan³

2023

Sci Rep

Self Cite

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Home use tests to monitor hormone trends during the menstrual cycle have been available over-the-counter for a long time. However, these tests often depend upon manual readouts and hence may lead to false analysis. Furthermore, a lot of these tests are also not quantitative. The aim of this study was to evaluate the accuracy of the quantitative home-based fertility monitor, Inito Fertility Monitor (IFM) and to use it to identify novel hormone trends in natural menstrual cycles. There were two aspects to our analysis: (i) Evaluating the efficacy of Inito Fertility Monitor in the measurement of urinary Estrone-3-glucuronide (E3G), Pregnanediol glucuronide (PdG) and Luteinizing hormone (LH), and (ii) A retrospective study of patients' hormone profiles using IFM. To evaluate the efficacy, the recovery percentage of the three hormones from IFM was evaluated using standard spiked solutions, the accuracy of measurement was calculated and the correlation between reproducible values from IFM and ELISA was established. During the validation of IFM, novel hormone trends were also observed. In order to reinforce the observations, a second group of 52 women was recruited. Assessment of the accuracy of IFM and evaluation of the volunteer urine samples was performed in a laboratory. Home assessment of hormone analysis was carried out using IFM. For the validation study, 100 women aged 21–45 years with cycle lengths ranging from 21 to 42 days were recruited. The participants had no previously diagnosed infertility conditions and their cycle lengths did not vary for more than 3 days from the expected cycle length. Daily first morning urine samples were collected from these 100 women. For the second group, 52 women were selected meeting the same criteria set for the validation study and IFM was provided to these women for testing at home. Coefficient of variation and recovery percentage of IFM with respect to laboratory based ELISA. Percentage occurrence of novel hormone trends and AUC analysis of a novel criteria identified for confirming ovulation. We observed that with all three hormones, IFM had an accurate recovery percentage. We found that the assay has an average CV of 5.05% in PdG measurement, 4.95% in E3G measurement and 5.57% in LH measurement. Furthermore, in predicting the concentration of E3G, PdG and LH in urine samples, we show that IFM has a high correlation with ELISA. In this study, we could also reproduce hormones trends across the menstrual cycle that have been observed by previous studies. We also identified a novel criterion for earlier confirmation of ovulation which could accurately distinguish ovulatory from anovulatory cycles with 100% specificity and had an area under the ROC curve of 0.98. In addition, we identified a new hormone trend which could be observed in 94.5% of the ovulatory cycles. 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. 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.Trial registration: The trial is registered at the current controlled trials ISRCTN registry #ISRCTN15534557.

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

Cited by 8 publications

References 19 publications

Gonadotropin and Ovarian Hormone Monitoring: Lateral Flow Assays for Clinical Decision Making

Gonadotropin and Ovarian Hormone Monitoring: Lateral Flow Assays for Clinical Decision Making

Survey Analysis of Quantitative and Qualitative Menstrual Cycle Tracking Technologies

Validation of urinary reproductive hormone measurements using a novel smartphone connected reader

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