Continuous Overnight Monitoring of Body Temperature During Embryo Transfer Cycles as a Proxy for Establishing Progesterone Fluctuations by Comparison with P4 Blood Progesterone Results: A Prospective, Observational Study

Background A prospective, observational study to identify relationships between body temperature and levels of peripheral P4 blood progesterone, and examine if these differ according to body temperature cycle pattern. Methods 62 data points from 18 patients undergoing hormone assisted embryo transfer cycles at IVIRMA IVF clinics in Madrid, Mallorca and Malaga, Spain volunteered to use OvuSense, an intra-vaginal body temperature monitor. Primary outcome measures were OvuSense Raw and Smooth Temperature (ST) (°C), P4 (ng/ml). Secondary outcome measures: Ongoing Pregnancy, Miscarriage or biochemical pregnancy. Graphical time based comparison analyses and multilevel regression analyses using MLwiN 3.10 ¹ software were conducted. Results A graphical analysis showed an apparent relationship between P4 levels and Temperature taken on P4 blood draw day. A multilevel regression analysis using MLwiN 3.10 ¹ software investigated this relationship, allowing between-patient variation to be accounted for and estimated. This established a strong linear relationship between LnP4 and ST, and cross correlation was carried out which identified the optimum predictor of levels of LnP4 was ST measured on the day prior to blood sampling. Further graphical analyses showed an apparent lower luteal level of P4 for cycles flagged as atypical by OvuSense, and for negative outcomes, except on embryo transfer day. Conclusions The results provide extremely strong evidence of a linear relationship between LnP4 and Smooth Temperature (ST) measured the day before blood sampling (Z = 15.6, p < 0.0001, 2 sided). This suggests that ST could provide a less invasive, continuous, and more practical method of assessing P4 response. Secondary outcomes may be related to ST pattern established during an embryo transfer cycle. Further investigation is required to establish the value of the ST pattern for improving outcomes.