Validation of urinary reproductive hormone measurements using a novel smartphone connected reader
Pattnaik et al.
The finding, in our words
The Inito Fertility Monitor demonstrated strong agreement with laboratory ELISA for measuring urinary estrone-3-glucuronide, pregnanediol glucuronide and luteinising hormone, with coefficients of variation around 5%. It identified a novel ovulation confirmation criterion that distinguished ovulatory from anovulatory cycles with 100% specificity and an area under the curve of 0.98, supporting accurate decentralised fertility monitoring.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
Handelsman et al. validated a direct LCMS assay for pregnanediol glucuronide in dried urine spots without deconjugation. In ten women monitored across one menstrual cycle, using two or three consecutive first-void samples reduced false-negative ovulation detection from eight per cent to 2.6 per cent and 1.9 per cent respectively, enabling accurate home-based fertility assessment.
Handelsman et al., The Journal of steroid biochemistry and molecular biology (paywalled) · source ↗
The Mira fertility monitor's LH surge and urine E1-3G levels correlated strongly with the ClearBlue Fertility Monitor's LH surge and low-to-high shift in both postpartum and perimenopause transitions, supporting at-home urine hormone monitoring for fertility tracking.
Bouchard et al., Women's health reports · source ↗
All five at-home urine ovulation predictor kits demonstrated high accuracy (92–97%) when compared with blood LH levels, though sensitivity varied widely from 38% to 77% with Clinical Guard the lowest. Patient experience was comparable across kits, though Clinical Guard was slightly less favoured for future use.
Vanderhoff et al., Fertility and sterility (paywalled) · source ↗
At-home urine oestrone-3-glucuronide measured with the Mira Fertility Tracker during gonadotropin stimulation correlated well with paired serum oestradiol (r = 0.761) and predicted mature oocyte yield to a similar degree, suggesting that patient-centric oestrogen monitoring could reduce reliance on clinic-based venous draws during fertility treatment.
In 20 women providing 73 paired samples across menstrual‑cycle phases, urinary metabolites measured at home correlated strongly with serum hormone concentrations (estradiol R²=0.96, progesterone R²=0.95, LH R²=0.98). When the derived equations were applied to a separate set of 20 users, predicted serum values correlated 0.92–0.94 with actual measurements. This suggests home urine testing could substitute for clinic blood draws in routine fertility monitoring, though the cohort was limited to women with normal cycles.
Pattnaik et al., Human reproduction open · source ↗