An assessment of salivary hormone estradiol and progesterone measurements in ART monitoring: A United States and European multi-center study.

ABSTRACT Research Question : Ovarian stimulation (OS) during in vitro fertilization (IVF) cycles involves close monitoring of estradiol (E2), progesterone (P4) and ultrasound measurements of follicle growth. In contrast to blood draws, sampling saliva is less invasive. Here, we present a blind validation of a novel saliva-based E2 and P4 assay performed in samples collected in independent IVF clinics. Design : Concurrent serum and saliva samples were collected from 324 patients at 6 large independent IVF laboratories. Saliva samples were frozen and run blinded. A further 18 patients had samples collected more frequently around the time of HCG trigger. Saliva samples were analyzed using an immunoassay developed with Salimetrics LLC. Results : In total, 652 pairs of saliva and serum E2 were evaluated, with correlation coefficients ranging from 0.68 to 0.91. In the European clinics a further 237 of saliva and serum P4 samples were evaluated however the correlations were generally poorer, ranging from -0.02 to 0.22. In the patients collected more frequently, 5 of 18 patients (27.8%) showed an immediate decrease in E2 after trigger. When P4 samples were assessed after trigger 8 of 18 (44.4%) showed a continued rise. Conclusions : Salivary E2 hormone testing correlates well to serum based assessment, while P4 values, around the time of trigger are not consistent from patient to patient.