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.

Dissociation between Cervical Mucus and Urinary Hormones during the Postpartum Return of Fertility in Breastfeeding Women

Identifying the return of fertility with cervical mucus observations is challenging during the postpartum period. Use of urinary measurements of estrogen and progesterone can assist in understanding the return to fertility during this period. The purposes of this study were to describe the postpartum return of fertility by an analysis of total estrogen (TE) and pregnanediol glucuronide (PDG) profiles and to correlate these profiles with cervical mucus observations. Twenty-six participants collected urine samples during the postpartum period and recorded mucus scores. TE and PDG hormones were analyzed and compared with mucus scores. During amenorrhea, mucus reflected TE changes in only 35 percent of women; after amenorrhea, typical mucus patterns were seen in 33 percent of cycles. We concluded that postpartum mucus and hormone profiles are significantly dissociated but that monitoring urinary hormones may assist in identifying the return of fertility. We also identified different hormonal patterns in the return to fertility. The postpartum period is a challenging time for identifying the return of fertility. The purposes of this study were to describe the hormonal patterns during the return of fertility and to correlate these patterns with cervical mucus observations. Twenty-six postpartum women collected urine samples and recorded mucus scores. Urinary estrogen and progesterone hormones were analyzed and compared with mucus scores. Before the return of menses, mucus reflected hormonal changes in only 35 percent women and after first menses in 33 percent of cycles. We found that hormone profiles do not correlate well with mucus observations during the postpartum return of fertility.

Hormonal pattern in prostatic cancer I. Correlation with local extent of tumour, presence of metastases and grade of differentiation

In 32 subjects with histologically and/or cytologically verified prostatic cancer the hormonal pattern was studied by assaying 18 plasma and urinary hormones or groups of hormones. The tumours were classified according to the UICC classification system and the hormone values were correlated to the local extent of the tumour (T classification), the presence of metastases (M classification) and the differentiation grade (G classification). It was found that patients with metastases had significantly higher plasma oestradiol and lower testosterone/oestradiol and testosterone/oestrone plus oestradiol ratios as compared to those subjects without metastases. In subjects with moderately or poorly differentiated tumours plasma oestrone + oestradiol was significantly higher and the testosterone/oestrone + oestradiol ratio was significantly lower than in the subjects with well differentiated tumours. In the various TNM classification groups no obvious trends were found with regard to urinary hormones and no significant differences between the groups for plasma FSH, LH, prolactin, progesterone and cortisol were observed. It is concluded that in more advanced cases with metastatic cancer and when tumours are less well differentiated the androgen/oestrogen ratio may be decreased. These alterations have no diagnostic significance because of great overlapping of individual results between the various groups of patients.

Hormonal pattern in prostatic cancer

In 32 subjects with histologically and/or cytologically verified prostatic cancer the hormonal pattern was studied by assaying 18 plasma and urinary hormones or groups of hormones and relating the values to the response to endocrine treatment. Total orchidectomy (orchiepididymectomy) was performed on 9 patients, subcapsular orchidectomy on 13 patients and oestrogen therapy with Estradurin® was given in 4 patients. Six patients had total orchidectomy followed by oestrogen therapy. With few exceptions all values were within the normal range. The only significant exceptions were the high urinary oestrogen values and the low urinary oestrone + oestradiol/oestriol ratio observed as compared to healthy males working in a factory. No urinary hormone values or ratios of hormone values could be used for the prediction of prognosis in prostatic carcinoma patients. However, the ratios of plasma testosterone/oestradiol (T/Oe2) and testosterone/prolactin (T/Prl) were found to give good information with regard to the response to endocrine treatment. High values for one or both of these ratios meant a good response to treatment in all subjects without exception in this material. Subjects with both ratios low had a good response to endocrine treatment in 50% of the cases. No other plasma hormones measured were of any help prognostically. It is concluded that by measuring the T/Oe2 and T/Prl ratios it seems possible to select a group of patients with favourable primary response to endocrine treatment.

Urinary Pregnanediol, Oestrogens, L.H. and F.S.H. during the Normal Menstrual Cycle

The determination of urinary hormones is useful in the assessment of gonadal and pituitary function. For interpretation of these parameters it is essential to establish normal values. This paper describes some of the methods used and results obtained in the determination of urinary pregnanediol, oestrogens, L.H. and F.S.H. during a number of normal cycles.