Ferring Pharmaceuticals announces results of the IRIS Study: A comparative analysis of individualised vs.conventional recombinant follicular stimulating hormone dosing in Indian infertile patients

Ferring Pharmaceuticals announces results of the IRIS Study: A comparative analysis of individualised vs.conventional recombinant follicular stimulating hormone dosing in Indian infertile patients

Singapore – 03 May, 2025 – Ferring Pharmaceuticals will today present results of the IRIS study, the world’s first randomised controlled trial (RCT) in ovarian stimulation for Indian patients, at the Asia Pacific Initiative on Reproduction (ASPIRE) annual congress in Singapore. The study shows comparable efficacy and safety of individualized dosing of follitropin delta versus conventional dosing of follitropin alfa on ovarian stimulation, with reported rates of ongoing pregnancy rate and live birth rate in follitropin delta numerically higher. These findings increase options in clinical practice for a patient population that has been under-researched and who have been believed to experience lower in vitro fertilisation (IVF) success rates.

Ovarian stimulation with FSH is an essential procedure for retrieval of oocytes for IVF or intracytoplasmic sperm injection (ICSI). However, considerable variation exists between women in oocyte yield2. Individualised dosing is a strategy that can be applied to optimise the number of retrieved oocytes while also limiting the risk of early ovarian hyperstimulation syndrome (OHSS). These data demonstrates this approach can also be an option for Indian patients.

IRIS was a trial conducted across multiple fertility clinics in India as a bridging study to evaluate the efficacy and safety of individualised follitropin delta dosing compared to conventionally dosed follitropin alfa during the first ovarian stimulation cycle for IVF or ICSI. More than 200 infertile Indian women aged 21-40 years were enrolled, randomized in a 1:1 ratio to receive either individualized follitropin delta (FE 999049) dosing, based on serum anti-Müllerian hormone (AMH) levels and body weight, or conventional follitropin alfa dosing. The primary endpoint was ongoing pregnancy rate, with secondary endpoints including number of oocytes retrieved, follow up data on live birth rate and safety profiles.

Key Findings:

• The primary endpoint of ongoing pregnancy rate was numerically higher in the follitropin delta group vs. follitropin alfa (22.2% vs 14.9%)
• The individualised follitropin delta dosing regimen was comparable to conventional follitropin alfa dosing in terms of the number of oocytes retrieved.
• The safety profile of individualised follitropin delta was consistent with that of conventional follitropin alfa, with no new safety concerns identified.
• Live birth rate was also numerically higher in the follitropin delta group (21.2% vs 14.9%). Neonatal health outcomes were similar with a low incidence of adverse events and congenital anomalies in both groups.
• Individualized dosing allows for a tailored approach, potentially optimising ovarian response and reducing the risk of OHSS.

Kelle Moley MD, Global Head of Reproductive Medicine and Maternal Health Science & Medical, Ferring Pharmaceuticals, said: “Indian patients are an understudied population for the effectiveness of assisted reproductive technology and we are proud that Ferring has been the first company to bring forward this standard of clinical trial evidence. We hope this opens the door for more research focused on the unmet needs of Indian patients. We are pleased to note we were able to demonstrate  numerically higher ongoing pregnancy and live birth rates for follitropin delta versus the comparator.”

Lead Investigator Dr. Nayana Patel from Akanksha Hospital and Research Institute, Gujarat, commented, “The IRIS study provides robust evidence supporting the use of individualized follitropin delta dosing in Indian patients. This personalized approach aligns with the principles of precision medicine, offering potential benefits in terms of efficacy and safety.”

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 Follitrophin 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 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 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. Dhillon et al, Investigating the effect of ethnicity on IVF outcome, Reproductive BioMedicine Online, Vol 31, Issue 3. P. 356-363;; 2015. https://doi.org/10.1016/j.rbmo.2015.05.015
2. Jirge PR, Patil MM, Gutgutia R, Shah J, Govindarajan M, Roy VS, Kaul-Mahajan N, Sharara FI. Ovarian Stimulation in Assisted Reproductive Technology Cycles for Varied Patient Profiles: An Indian Perspective. J Hum Reprod Sci. 2022;15(2):112-25.
3. Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2017. Approved on 12 December 2016 and last updated on the EMA website in October 2023. Available from https://www.ema.europa.eu/en/medicines/human/EPAR/rekovelle [Accessed April 2025]
4. Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521
5. 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.
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. Lambalk CB, Banga FR, Huirne JA, et al. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type. Hum Reprod Update 2017;23: 560-579.
8. Toftager M, Bogstad J, Lossl K, et al. Cumulative live birth rates after one ART cycle including all subsequent frozen-thaw cycles in 1050 women: secondary outcome of an RCT comparing GnRH-antagonist and GnRH-agonist protocols. Hum Reprod 2017;32: 556-716 567.