Ferring Pharmaceuticals has announced results from the IRIS study, marking a significant milestone as the world's first randomized controlled trial specifically designed to evaluate ovarian stimulation protocols in Indian infertile patients. The study demonstrates that individualized dosing of follitropin delta achieves numerically superior pregnancy and live birth rates compared to conventional follitropin alfa dosing, potentially addressing treatment gaps in an under-researched patient population.
Study Design and Patient Population
The IRIS trial was conducted across multiple fertility clinics in India as a bridging study to evaluate the efficacy and safety of individualized 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 and 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 Clinical Outcomes
The study revealed several important findings that support the use of individualized dosing strategies:
The primary endpoint of ongoing pregnancy rate was numerically higher in the follitropin delta group versus follitropin alfa (22.2% vs 14.9%). Live birth rate was also numerically higher in the follitropin delta group (21.2% vs 14.9%).
The individualized follitropin delta dosing regimen was comparable to conventional follitropin alfa dosing in terms of the number of oocytes retrieved, indicating similar ovarian response between treatment groups.
Neonatal health outcomes were similar with a low incidence of adverse events and congenital anomalies in both groups, demonstrating the safety of the individualized approach.
Safety Profile and Clinical Significance
The safety profile of individualized follitropin delta was consistent with that of conventional follitropin alfa, with no new safety concerns identified. The individualized dosing approach allows for a tailored treatment strategy, potentially optimizing ovarian response and reducing the risk of ovarian hyperstimulation syndrome (OHSS).
Dr. Kelle Moley, global head of reproductive medicine and maternal health science & medical at Ferring Pharmaceuticals, emphasized the significance of this research: "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."
Expert Perspectives on Personalized Medicine
Lead Investigator Dr. Nayana Patel from Akanksha Hospital and Research Institute, Gujarat, commented on the study's implications: "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."
Treatment Innovation and Mechanism
Follitropin delta represents a significant advancement in reproductive medicine as the first recombinant FSH derived from a human cell line (PER.C6 cell line). It is structurally and biochemically distinct from other existing rFSH gonadotrophins and features an approved dosing algorithm designed for predictable ovarian response.
The individualized dosing of follitropin delta is determined using an approved algorithm based on a woman's AMH level and body weight. AMH serves as a biomarker to assess ovarian reserve and can help predict ovarian response. The follitropin delta dose should be based on AMH level, measured using specific immunoassays from Roche, Beckman Coulter, or Fujirebio.
Clinical Context and Future Implications
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 yield, making individualized dosing strategies particularly valuable for optimizing treatment outcomes while limiting risks.
The IRIS study findings increase treatment options in clinical practice for a patient population that has been under-researched and who have been believed to experience lower in vitro fertilization success rates. This research represents an important step toward addressing unmet medical needs in reproductive medicine for Indian patients and may pave the way for additional population-specific studies in assisted reproductive technology.
