PARIS -- Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction. These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications.[1,2]

The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI.[3] The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrieved.

Currently, follitropin delta is approved for use via a dosing algorithm based on serum anti-Müllerian Hormone (AMH) and bodyweight individualised for each patient, and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile. The clinical value of this approach has been well established[4,5,6,7,8], particularly in treatment-naïve patients where the algorithm aims to achieve 8-14 retrieved oocytes while minimising the risk of ovarian hyperstimulation syndrome (OHSS) to optimise the live birth rate in a fresh and frozen transfer cycle.[4,5,6,7,8]

Key Findings:

· Ovarian Response: Both treatment groups achieved a mean of 9.9 oocytes retrieved, indicating similar efficacy
· Clinical Pregnancy Rates: Clinical pregnancy rates were similar for follitropin delta 31.6% versus 31.0% for follitropin alfa
· Drug Product Usage: After measurement unit conversion, the mean total dose patients were exposed to was numerically lower for follitropin delta (143.7±33.6 µg) than follitropin alfa (154.3±23.1 µg or 2,105±315 IU)
· OHSS Rates: Early OHSS rates were low (2.5% for follitropin delta and 3.0% for follitropin alfa), with no cycle cancellations due to excessive ovarian response on either arm of the study.

Dr Andrea Bernabeu, Medical Director at Instituto Bernabeu and principal investigator of the ADAPT-1 trial, said: “No patients we see as fertility doctors are the same and the ability to optimise therapy based on patients age, treatment goal and whether they have a high or low response to follicular stimulation are all relevant. These data provide confidence and expand our understanding for dosing in follitropin delta.”

Pierre-Yves Berclaz, Chief Science and Medical Officer at Ferring Pharmaceuticals, stated: “The ADAPT-1 trial results confirm the efficacy and safety of follitropin delta across the full range of dosing strategies, making it the only recombinant FSH with robust clinical evidence supporting multiple dosing strategies. Ferring will take forward the implications of this study in future dialogue with regulatory authorities.”