• Data presented today at the ESHRE congress builds evidence for conventional-based Follicular Stimulating Hormone (FSH) dosing for Rekovelle® (follitropin delta); alongside its existing unique algorithm-based dosing

 

PARIS -- (BUSINESS WIRE) --

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 established4,5,6,7,8, 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."

About GnRH protocols

Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI.7,8

About Follitropin Delta (Rekovelle®)

Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response.3 It is the first rFSH derived from a human cell line (PER.C6® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins.3,4 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight.3,5 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.5,6 The follitropin delta dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.3

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in areas of gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries.

Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X.

REFERENCES

1 – Arce JC, Larsson P, Garcia-Velasco JA; Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa; RBMO; 2020

2 – Yang R, Zhang Y, Liang X et al; Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization / intracytoplasmic sperm injection; Reproductive Biology and Endocrinology; 2022

3 – Clinical Trials.gov page: https://clinicaltrials.gov/study/NCT05263388 (Accessed June 2025)

4 – Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396.

5 – Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, Arce JC; ESTHER-2 Study Group. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482.

6 – Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17.

7 – Qiao J, Zhang Y, Liang X, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29.

8 – Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578.