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Follitropin delta – first human cell line derived recombinant FSH for AMH and body weight adjusted ovarian stimulation – an eight center, retrospective analysis of clinical practice data

Published:December 21, 2021DOI:https://doi.org/10.1016/j.rbmo.2021.12.013

      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 AMH as shown in the ESTHER-1-trial be confirmed in routine clinical practice?

      Design

      In eight centers for reproductive medicine in Germany observational data of 360 women who underwent ovarian stimulation with follitropin delta have been evaluated as part of the quality control from January 2018 to June 2019. The data were analyzed retrospectively.

      Results

      Mean age of patients was 33.5 (± 3.8) years. Pretreatment AMH levels range from < 0.5 ng/ml/ 3,6 pmol/l (2.5%) to > 5.6 ng/ml/40 pmol/l (19.7%) with 79.7% of all AMH measurements above 2.0 ng/ml /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 8 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 controlled ovarian hyperstimulation with follitropin delta remains highly effective in clinical practice.

      KEYWORDS

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      Biography

      Annette Bachmann MD, PhD (University Hospital Frankfurt, Germany, Department of Gynecology and Obstetrics) is head of division of reproductive endocrinology. She obtained her doctorate from Eberhard Karls University in Tübingen, Germany and trained at University Hospitals in Tübingen, Frankfurt, Germany and Indiana Center of Biomedical Innovation ICBI, Indiana, USA.
      KEY MESSAGE
      In a multi-center, application-oriented setting follitropin delta, the first recombinant FSH expressed in a human cell line with algorithm-based individualized dosing has proven to remain predictable in real life with very diverse patient characteristics including with a wide range of AMH levels.