Latest news with #ESHRE
National Post
03-07-2025
- Health
- National Post
Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta
Article content 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 Article content 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. Article content 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.' Article content 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.' Article content About GnRH protocols Article content 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. Article content REFERENCES Article content 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 Article content 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 Article content 3 – Clinical page: (Accessed June 2025) Article content 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. Article content 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. Article content 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. Article content 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. Article content 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. Article content Article content Article content Article content Article content Contacts Article content For more information, please contact Article content M Article content atthew Worrall Article content Article content Article content Article content
Business Upturn
02-07-2025
- Health
- Business Upturn
Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta
Business Wire India 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 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 page: (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 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
The Independent
02-07-2025
- Health
- The Independent
Major microplastics finding raises fertility fears
Scientists have detected microplastic particles in human semen and female reproductive fluids for the first time. The new study, presented at ESHRE, found microplastics in nearly 70 percent of female follicular fluid samples and 55 percent of male semen samples. Common microplastic polymers, including PTFE, polystyrene, and polyethylene terephthalate, were identified in these reproductive fluids. This discovery raises concerns about potential risks to human health and fertility, building on previous research linking microplastics to inflammation, DNA damage, and hormone disruption. While direct impacts on fertility require further study, experts suggest reducing exposure by using glass containers and limiting water consumption from plastic bottles.
Business Wire
02-07-2025
- Health
- Business Wire
Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta
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 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." 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 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 page: (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.
Yahoo
02-07-2025
- Health
- Yahoo
Groundbreaking study finds microplastics in semen and female reproductive fluid
Scientists have detected potentially toxic microplastic particles in human semen and female reproductive fluids for the first time, raising concerns about potential risks to health and fertility. A growing body of research warns that these nearly ubiquitous tiny particles, under 5mm in size, pose a threat to environmental and public health. Previous research has shown that in tissues where microplastics accumulate, these particles can induce inflammation, free radical formation, DNA damage, cellular senescence, and hormone disruptions. A recent study also detected microplastics in human penis samples raising concerns about their potential role in erectile dysfunction. Now, new research, presented on Tuesday at the 41st Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), looked for microplastics in semen from 22 men and follicular fluid from 29 women. Researchers found tiny particles of several commonly used microplastic polymers, including polytetrafluoroethylene (PTFE), polystyrene (PS), polyethylene terephthalate (PET), polyamide (PA), polypropylene (PP) and polyurethane (PU), in both fluids. Overall, the new study found microplastics in nearly 70 per cent of the follicular fluid samples analysed. PTFE was the most prevalent, present in nearly a third of the samples, researchers found. About 55 per cent of the analysed semen samples contained microplastics, with PTFE again emerging as the most prevalent polymer. Researchers ruled out contamination as a possible reason for the findings since the samples were collected and stored in glass containers, and underwent chemical treatment before analysis. 'Previous studies had already shown that microplastics can be found in various human organs. As a result, we weren't entirely surprised to find microplastics in fluids of the human reproductive system,' lead scientist Emilio Gomez-Sanchez said. 'But we were struck by how common they were – found in 69 per cent of the women and 55 per cent of the men we studied,' Dr Gomez-Sanchez said. While it is 'possible they could impair egg or sperm quality' in humans, scientists say they 'do not yet have enough evidence to confirm that'. Researchers hope to expand their analysis to a larger population, along with a detailed lifestyle and environmental exposure questionnaire. While studies point to several environmental factors influencing fertility, measuring the direct impacts of different agents remains a challenge. 'There's no need for alarm at this point. Microplastics are just one of many elements that may play a role in fertility,' Dr Gomez-Sanchez said. 'However, it is sensible to consider ways of reducing our exposure to them. Simple steps, such as using glass containers to store and heat food, or limiting the amount of water we consume from plastic bottles, can help minimise our intake,' he said.
