Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta
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
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
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)
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250702267462/en/
Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same.
Ahmedabad Plane Crash
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
3 hours ago
Massachusetts advocates fear Trump's bill will unravel health safety net in Obamacare's model state
BOSTON -- In the state that served as the model for Obamacare, advocates and health care workers fear the Trump administration is trying to dismantle piece-by-piece a popular program that has provided insurance, preventive care and life-saving medication to hundreds of thousands of people. Provisions contained in both the Senate and House versions of the massive tax and spending cuts bill advancing in Congress — a centerpiece of President Donald Trump's agenda — could strip health insurance from up to a quarter of the roughly 400,000 people enrolled in the Massachusetts Health Connector, according to state estimates. The changes would create anew the coverage gaps state leaders were working to close when Massachusetts in 2006 became the first U.S. state to enact a law requiring nearly every resident to have health insurance, state officials say. Beyond the effect on residents' health, losing care could have broader repercussions — both for the program's finances and residents' ability to make a living. 'The idea of needing to unwind that now and pull back on that promise and commitment is really frustrating and heartbreaking and cruel and counterproductive,' said Audrey Morse Gasteier, executive director of Massachusetts' health insurance marketplace. Trump and Republican supporters in Congress say the changes, which include new documentation requirements and limitations on who can apply for tax credits to help pay for insurance, are necessary to root out what they call fraud, waste and abuse. The Affordable Care Act changes proposed in both versions of the bill, along with massive cuts to Medicaid and other programs, would eliminate roughly $1.1 trillion in health care spending over the next decade, according to the nonpartisan Congressional Budget Office. In Lawrence, a mill community of around 90,000 people on the Merrimack River, where more than 80% of the population is Hispanic or Latino, Kesia Moreta said she's already seeing people slip out of the state's health care network because of the Trump administration's aggressive effort to crack down on illegal immigration. Moreta, who manages a program created under the ACA that helps people sign up for coverage, said clients have been missing meetings out of fear that being enrolled for health insurance will harm their effort to stay in the U.S. legally. Recently, a father of a U.S.-born teenage son with epilepsy deleted every email related to his health plan and stopped answering calls from the Connector after watching reports about deportations on social media. When his son's medication ran out, Moreta said the father finally reached out, whispering over the phone, 'Is this going to get me deported?' 'That breaks our hearts,' Moreta said. More than 98% of Massachusetts residents have health insurance, the lowest rate of uninsurance in the country, according to the Massachusetts Health Insurance Survey. Vicky Pulos, an attorney for the Mass Law Reform Institute who helps low-income people gain access to health care, said Republicans who tried and failed to repeal the Affordable Care Act during the first Trump administration have decided to take it apart incrementally despite its growing popularity. 'It really seems like this is just a less transparent way of effectively dismantling the accomplishments of the Affordable Care Act in both Medicaid and the marketplace,' Pulos said. The changes, she added, 'will massively drive up the number of uninsured but without openly repealing the ACA.' Another provision included in both the House and Senate bills would require people applying for or renewing coverage to provide more documentation of their income, household size and immigration status to be eligible for premium tax credits when the state marketplace already has that information, which Morse Gasteier said would cause 'friction, red tape and delays.' The Trump administration has said the proposals will 'put a stop' to immigrants 'stealing taxpayer-funded health care benefits meant for American citizens.' No states use federal money to provide health insurance to people who are in the U.S. illegally. Some, like Massachusetts, use state tax dollars to do so to provide basic primary care services for a small population of vulnerable residents, like children. No undocumented immigrants receive insurance through the state marketplace. Of the 400,000 enrolled in the state marketplace, around 60,000 are noncitizens who are in the U.S. legally and would lose access to federal premium tax credits if either chamber's version of the bill becomes law. The number includes domestic violence and human trafficking victims, refugees, people granted asylum or humanitarian parole, temporary protected status and other work-authorized immigrants. Without the credits, premiums will cost upwards of $500 or $600 — an increase many people can't afford, Morse Gasteier said. Around half are green-card holders with an annual income of $15,000 a year or less. The remaining 40,000 people expected to lose coverage are U.S. citizens Morse Gasteier said could be stymied in applying or recertifying coverage by provisions like the increased documentation requirements. Morse Gasteier said Massachusetts' marketplace worked 'tirelessly' to enroll vulnerable and hard-to-reach populations after the state program — formed under the leadership of then-Gov. Mitt Romney and known as 'Romneycare" — was created. She worries that if people hear help is no longer available, 'entire populations will just sort of give up on health insurance.' In addition to affecting residents' health, that could have an economic impact in the state. Immigrants with legal status enrolled in the state marketplace tend to be younger than the rest of the population, Morse Gasteier said. Their presence brings premiums down for others because they tend to be healthier. In Lawrence, advocates who help people obtain insurance coverage though the ACA marketplace say the burden would fall disproportionately on people with chronic health issues like diabetes and chronic heart disease. The Greater Lawrence Community Action Council assists around 10,000 people a year with either signing up for or renewing health insurance. 'If you're not healthy, let me tell you, you can't work. If you can't work, you can't pay your bills. It's just as simple as that,' said GLCAC CEO Vilma Martinez-Dominguez. Moreta said one man who called her from the emergency room recently said he discovered his health insurance had lapsed. Moreta said she could help him renew it, and urged him to wait at the hospital. He told her not to do anything. He was leaving the hospital. She has no idea what became of him.
CNN
10 hours ago
- CNN
U.S. House takes up Trump Agenda bill
The House takes up the revised Senate version of President Trump's sweeping domestic agenda bill, which passed the Senate on Tuesday by the slimmest of margins. CNN Political Analyst and Historian Leah Wright Rigueur says if the bill becomes law, people will remember Donald Trump as the President who increased the national debt and took away people's healthcare.
10 hours ago
Former CDC officials warn proposed budget cuts could cost American lives in 2026
Proposed funding cuts to the Centers for Disease Control and Prevention in the fiscal year 2026 federal budget will lead to significant negative health impacts for millions of Americans, a coalition of former federal health officials said. These proposed funding cuts are not related to the " big, beautiful bill" that is making its way through Congress. The press conference was organized by CDC Alumni and Friends and Fired But Fighting, an informal network of public health advocates. The latter has created a website that lays out the proposed budget cuts to the CDC. The former officials spoke out during a press conference on Wednesday noting that the proposed budget would slash CDC's budget by more than half (54%), taking it from $9.3 billion to $4.2 billion. "Instead of investing in these lifesaving programs, the current budget leaves the American people to pay the price tag with both their lives and money," said Brian King, a former health official at the CDC and Food and Drug Administration, who worked on tobacco prevention. State and local health departments would also be greatly impacted by the proposed cuts with over half of their budgets coming from federal dollars, the advocacy group notes. Roughly 80% of the CDC's annual domestic budget is provided to these smaller, local health departments. About $4.7 billion was provided in 2023 alone in grants to support health departments, hospitals, universities and nonprofits across the country, the group said. As a result of cuts to CDC funding for local health departments, "Americans will be sicker and more will be losing their lives unnecessarily," Dr. Tom Farley, a former health commissioner of Philadelphia and New York City, predicted. One of the largest cuts would be to chronic disease prevention, the former officials noted, including tobacco prevention, HIV prevention and injury prevention, which includes drownings -- a leading cause of death in young kids. "Successful [HIV prevention] programs that Americans have depended on for decades to help protect their own health and the health of their families and their local communities now risk being irreversibly damaged," said Dr. John Brooks, a former CDC official in charge of the agency's response to COVID, mpox and HIV.
