A new instrument to personalize ovarian stimulation: results of the CERES study after using a novel gonadotropin - follitropin delta.

ABSTRACT

Objective: The aim of the study CERES (CzEch REkovelle real life Study) was to gather experience with the use of a novel gonadotrophine, to evaluate the efficacy of follitropin delta in Czech clinical settings and to compare our results with the clinical trial ESTHER-1. METHODS: Individualized follitropin delta daily dose in µg based on the patient's anti-Müllerian hormone (AMH) level and body weight (AMH < 15 pmol/ L 12 µg/ d; AMH > 15 pmol/ L 0.10­0.19 µg/ kg/ d; max. 2 µg/ d). RESULTS: A total of 85 women (aged 24-42 years) was included in the study. The average patients age was 32.9 years, the average body weight was 67.8 kg, and the mean level of AMH was 23.2 pmol/ L. There were initiated 85 controlled ovarian stimulations with follitropin delta and 84 egg collections. Forty patients (47%) had optimal number of retrieved eggs (8-14), 75 patients (88%) had embryotransfer, 10 patients (12%) had no embryo suitable for transfer, 65 patients had single embryo transfer and 10 patients had 2 embryos for transfer. There were reported 37 clinical pregnancies (43.5% cPR - clinical pregnancy rate), 30 live births (35.3% LBR - live birth rate), 3 (3.5%) early moderate ovarian hyperstimulation syndroms (OHSS) and no hospitalization due to the treatment. CONCLUSION: Individualized ovarian stimulation optimizes ovarian response, maintains treatment efficacy and improves safety by reducing OHSS incidence. The results of the Czech population study are fully comparable with the international, randomized, assessor-blinded trial ESTHER-1.