Pattnaik, S., Das, D., Venkatesan, V. A., & Rai, A. (2023). Predicting serum hormone concentration by estimation of urinary hormones through a home-use device. Human reproduction open. https://doi.org/10.1093/hropen/hoac058
Pattnaik S, Das D, Venkatesan VA, Rai A. Predicting serum hormone concentration by estimation of urinary hormones through a home-use device. Human reproduction open. 2023. doi:10.1093/hropen/hoac058
Pattnaik, Siddharth, et al. "Predicting serum hormone concentration by estimation of urinary hormones through a home-use device." Human reproduction open, 2023.
Creative Commons Attribution-NonCommercial 4.0 International
Open Access
Free full text on PubMed Central (PMC9838318)
RRM Academy Synopsis
Home urine hormone readings track blood levels in regular cycles
A 2023 validation study of 20 women with regular cycles found that a home monitor's urine readings closely tracked laboratory blood levels of estradiol, progesterone and LH. The correlations (R2) were 0.96, 0.95 and 0.98 across 73 samples. A second group of 20 new users showed similar correlations.
Key Findings
Across 73 data points from 20 participants, serum estradiol, progesterone and LH correlated with urinary estrone-3-glucuronide, pregnanediol glucuronide and LH with an R2 of 0.96, 0.95 and 0.98, respectively.
In a verification cohort of 20 new users sampled on random cycle days, serum values predicted from the urine equations correlated with measured serum values at 0.92, 0.94 and 0.93.
Urinary estrone-3-glucuronide and pregnanediol glucuronide correlated linearly with serum estradiol and progesterone, while urinary LH and serum LH correlated by quadratic regression.
In all 11 data points where serum progesterone confirmed ovulation, urinary pregnanediol glucuronide also confirmed ovulation.
In the experimental cohort, first-morning urinary concentrations correlated better with serum hormones than creatinine-corrected values did.
Interpretation
The study is a device validation using a correlation design. Researchers compared home urine readings from the Inito Fertility Monitor with blood tests drawn on set cycle days. They checked the resulting equations in a separate group of new users. Participants were women aged 21 to 45 with regular cycles, none using hormonal contraception or fertility drugs. The authors note that correlation in women with infertility conditions still needs to be established. Two authors work for Samplytics Technologies, described in the paper as a forwarder for the monitor's maker, Inito, and two co-founded Inito. The study received no funding.
RRM Context
Fertility awareness depends on seeing hormone patterns across a full cycle. Blood tests capture single moments. The home monitor produced hormone values that followed laboratory results in women with regular cycles. Its progesterone metabolite reading also confirmed ovulation in every sample where blood progesterone did. The monitor offers a way to observe the luteal phase at home.
Our editorial summary of this paper, not the article's abstract.
Abstract
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
The trial was registered at the International Standard Randomised Controlled Trial Number (ISRCTN) registry (Identifier: ISRCTN15534557).
