EStradiol and PRogesterone in In vitro ferTilization (ESPRIT): a multicenter study evaluating third- versus second-generation estradiol and progesterone immunoassays

N P Polyzos,G Miles,H Tournaye,H Donner,J Schiettecatte,E Anckaert,G Bobba,W D J Verhagen-Kamerbeek,E Bosch,P Drakopoulos

doi:10.1007/s40618-020-01211-x

Abstract

PurposeTo assess estradiol (E2) and progesterone levels during ovarian stimulation determined by third-generation (Gen III) and second-generation (Gen II) Elecsys® immunoassays.MethodsE2 and progesterone concentrations were measured using Elecsys® Gen III and Gen II immunoassays, and progesterone concentrations on the day of ovulation triggering were determined by LC–MS/MS. This was a retrospective, non-interventional study conducted at European tertiary referral infertility clinics in women aged 18–45 years, with a body mass index 18–35 kg/m2, regular menses, and both ovaries.ResultsSerum samples were obtained from 230 women classified by oocyte retrieval as poor (33.0%; 0–3 oocytes), normal (40.9%; 4–15 oocytes), or high (26.1%; > 15 oocytes) responders. E2 and progesterone levels increased during ovarian stimulation, with greatest increases observed in high responders. Elecsys® Gen III and Gen II assay results were highly correlated for E2 (Pearson’s r = 0.99) and progesterone (r = 0.89); Gen III results were lower than Gen II for both E2 and progesterone. On the day of triggering, Gen III E2 and progesterone levels showed a difference of − 15.0% and − 27.9%, respectively. Progesterone levels (on day of triggering) measured by LC–MS/MS correlated better with Gen III (0.98) than Gen II (0.90). Mean relative differences for Gen III and Gen II assays versus LC–MS/MS were 14.6% and 62.8%, respectively.ConclusionE2 and progesterone levels determined with Elecsys® Gen II and III assays were highly correlated; results were lower for Gen III versus Gen II. Differences observed for progesterone on the day of triggering may be clinically relevant.

Highlights

Materials and methodsThe measurement of estradiol (E2) and progesterone is an essential part of ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI)
Our findings demonstrate that E2 levels determined with the Elecsys® Estradiol III assay are highly correlated with results determined using the well-established Elecsys® Estradiol II assay (r = 0.99); the correlation between Elecsys® Progesterone III and Elecsys® Progesterone II assay results was slightly weaker (r = 0.89)
We show that E 2 and progesterone levels determined by the Gen III assays were lower than with the Gen II assays, the differences are only of potential clinical relevance for progesterone

Summary

Introduction

Materials and methodsThe measurement of estradiol (E2) and progesterone is an essential part of ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). As hormone measurement during IVF or ICSI cycles is important for optimizing ovarian response and treatment safety and efficacy, several different assays have been developed for the measurement of E 2 and progesterone serum levels. Modern assays need to fulfil a number of criteria: have good precision to characterize patient response to treatment; be reliable over a wide concentration range; have high specificity for E2 and be able to exclude exogenous estrogens; and provide good interlaboratory reproducibility [8]. The Elecsys® second-generation (Gen II) Estradiol and Progesterone immunoassays have been widely used for monitoring serum E2 and progesterone levels. The Elecsys® third-generation (Gen III) Estradiol and Progesterone immunoassays have demonstrated good correlation with Gen II assays during assay development, but IVF patient samples were not available for validation

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