An eight centre, retrospective, clinical practice data analysis of algorithm-based treatment with follitropin delta

Abstract

Research question: Can efficacy and success rates of the first recombinant FSH expressed in a human cell line with an individualized dosing algorithm based on body weight and anti-Müllerian hormone (AMH) as shown in the ESTHER-1 trial be confirmed in routine clinical practice?

Design: In eight reproductive medicine centres in Germany, observational data of 360 women who underwent ovarian stimulation with follitropin delta were evaluated as part of the quality control from January 2018 to June 2019. The data were analysed retrospectively.

Results: Mean age of patients was 33.5 (±3.8) years. Pretreatment AMH concentrations ranged from <0.5 ng/ml or 3.6 pmol/l (2.5%) to >5.6 ng/ml or 40 pmol/l (19.7%), with 79.7% of all AMH measurements above 2.0 ng/ml or 14.5 pmol/l. The mean number of oocytes obtained in n = 359 first follitropin delta cycles was 11.2 (±6.7) oocytes with 42.1% of patients having between eight and 14 oocytes retrieved at oocyte retrieval. The average clinical pregnancy rate in the first cycle with a fresh embryo transfer was 38.2% with a mean of 1.4 embryos per transfer. The cumulative pregnancy rate was 49.4% for the first stimulation cycle (including cryopreservation cycles generated from the first stimulation cycle).

Conclusion: The goal of obtaining an adequate number of oocytes (8-14 oocytes) using the follitropin delta dosing algorithm was reached in 42.1% of patients despite a wide range of pretreatment AMH values, while achieving very good clinical pregnancy rates. Hence, algorithm-based ovarian stimulation with follitropin delta remains highly effective in clinical practice.

Keywords: AMH; Anti-Müllerian hormone; Dosing algorithm; Follitropin delta; Individualized therapy; Ovarian stimulation.