Continuous Overnight Monitoring of Body Temperature During IVF Cycles as
a Proxy for Establishing Progesterone Fluctuations: Prospective
Observational Study Comparing Peripheral P4 Blood Progesterone and
Intra-Vaginal Temperature Device
Abstract
Objective Pilot 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.
Design Prospective, observational study. Setting IVIRMA
IVF clinics in Madrid, Mallorca and Malaga, Spain. Population 62
data points from 18 patients undergoing hormone assisted
embryo-implantation cycles that volunteered to use OvuSense, an
intra-vaginal body temperature monitor. Main Outcome Measures
OvuSense Raw and Smooth Temperature (°C), P4 (ng/ml). 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 (Z = 15.6, p <
0.0001, 2 sided) of a linear relationship between LnP4 and Smooth
Temperature (ST) measured the day before blood sampling. This suggests
that ST could provide a less invasive, continuous, and more practical
method of assessing P4 response. Further investigation is required to
establish the value for improving outcomes.