Latest news with #EuropeanSocietyofHumanReproductionandEmbryology
Business Upturn
14 hours ago
- 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
Business Wire
19 hours ago
- 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.
Time of India
a day ago
- Health
- Time of India
SHOCKING! Scientists discovered microplastics in human reproductive fluids
Scientists have discovered microplastics in human reproductive fluids, raising concerns about potential risks to fertility and reproductive health. The study, presented at the ESHRE meeting, found microplastics in follicular fluid from women and seminal fluid from men. Researchers identified various common microplastic polymers, including PTFE, PS, and PET, prompting further investigation into the impact on reproductive health. Microplastics are everywhere - in the air you breathe, the water you drink, food you eat. It has even entered the living tissue. Scientists have discovered microplastics in human reproductive fluids. During the research presented at the 41st Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), the scientists revealed the presence of microplastics in human reproductive fluids. The recent discovery has raised concerns about its potential risks to fertility and reproductive health. What are microplastics Microplastics are plastic particles that are less than 5 millimeters (mm) in size. For better visualization, human hair is about 80,000 nanometers wide. There are also microplastics, which are even smaller, invisible to the naked eye, and measuring smaller than one-thousandth of a millimeter. They are known as nanoplastics. These microplastics are formed from the chemical breakdown, aka decomposition, of larger plastic waste, including food packaging (like single-use water bottles), synthetic fabrics, and personal care products. Microplastics in human reproductive fluids To see if microplastics have invaded living tissue, the researchers analyzed follicular fluid from 29 women and seminal fluid from 22 men, both of which play critical roles in natural conception and assisted reproduction. What they found was shocking. These reproductive fluids contained a variety of commonly used microplastic polymers, including polytetrafluoroethylene (PTFE), polystyrene (PS), polyethylene terephthalate (PET), polyamide (PA), polypropylene (PP), and polyurethane (PU). The scientists found the presence of microplastics in 69% of the follicular fluid samples, they analyzed. PTFE was the most common polymer, found in 31% of the samples. This was followed by PP (28%), PET (17%), PA (14%), polyethylene (PE) (10%), PU (10%), and PS (7%), in descending order of prevalence. They found microplastics in 55% of the seminal fluids collected from men. PTFE was the most prevalent polymer, identified in 41% of the samples. Other polymers detected included PS (14%), PET (9%), PA (5%), and PU (5%), though in lower concentrations. What are experts saying '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, but we were struck by how common they were – found in 69% of the women and 55% of the men we studied,' lead researcher Dr. Emilio Gomez-Sanchez said in a statement. Microplastics pose a threat to environmental and public health. Though the researchers have found the presence of microplastics in human reproductive fluids, they are yet to understand how it may affect fertility, and its possible implications for human reproductive health. 'What we know from animal studies is that in the tissues where microplastics accumulate, they can induce inflammation, free radical formation, DNA damage, cellular senescence, and endocrine disruptions. It's possible they could impair egg or sperm quality in humans, but we don't yet have enough evidence to confirm that,' Dr. Gomez-Sanchez added. They are planning to expand the research to include a larger cohort and collect detailed lifestyle and environmental exposure data. Further study would explore the potential relationship between the presence of microplastics and oocyte and sperm quality. Should you be concerned Dr. Gomez-Sanchez said that fertility is influenced by many factors, such as age, health, and genetics. He said that the recent findings should not cause alarm among those trying to conceive. 'There's no need for alarm at this point. Microplastics are just one of many elements that may play a role in fertility. 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. The Plastics Problem: Nano & Microplastics and Their Dangerous Impact on Heart Health 'Environmental factors influencing reproduction are certainly a reality, although not easy to measure objectively. The authors of this study found microplastics in over two-thirds of follicular fluids and more than 50% of semen fluids from the studied patients. Although the significance of these findings is not yet clear, they should be considered an additional argument in favour of avoiding the generalised use of plastics in our daily lives,' Professor Dr. Carlos Calhaz-Jorge, Immediate Past Chair of ESHRE, added. Get the latest lifestyle updates on Times of India, along with Doctor's Day 2025 , messages and quotes!
Time of India
a day ago
- Health
- Time of India
Health alert: Scientists discover plastic particles inside sperm and ovaries in alarming new research
First, it was air and water, then the placenta, brain, and even testicles. Now, minute fragments of plastic called microplastics are being found inside human reproductive fluids , prompting new questions about fertility and health. At the 41st annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Paris on July 2, Spanish researchers revealed that microplastics were present in 69 percent of follicular fluid samples (taken from 29 women) and 55 percent of semen samples (from 22 men). Microplastics are polymer fragments that range in size from less than 0.2 inches (5 millimetres) to 1/25,000th of an inch (1 micrometre). Polymers are chemical compounds with long chains of large and repetitive molecular units called monomers, and are known for being flexible and durable. Most plastics are synthetic polymers. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Cheap Cyprus Holiday Packages From The UK (Take A Look) BestSearches | Search Ads Undo 'These aren't isolated findings, it's widespread,' said Dr. Emilio Gómez-Sánchez, lead researcher from Next Fertility Murcia. The most common polymer detected was polytetrafluoroethylene (PTFE), better known as nonstick cookware coating, found in nearly one-third of women's samples and just over 40 percent of men's. Other plastics like polyethylene, polyurethane, polyamide, PET, polypropylene, and polystyrene also turned up in more than half of the female samples and over half of the male samples. Live Events Dr. Matthew Campen, a researcher at the University of New Mexico who previously detected microplastics in the brain and testicles, commented that the new findings are a warning light. 'It sets the stage for more advanced studies on plastics exposure and reproductive fitness,' he warned. But experts are quick to urge calm. 'There's no reason to panic,' Gómez‑Sánchez emphasized. 'Exposure isn't the only piece of a complex fertility puzzle,'. Still, the researchers intend to expand the study and examine whether microplastics might affect sperm or egg quality. How do microplastics enter the body? Microplastics enter the body through ingestion, inhalation, and even skin contact. Once in the bloodstream, they migrate throughout the body, lodging in organs, including reproductive ones. Studies in animals show microplastics can generate inflammation, DNA damage, free radicals, and hormonal disruption. But scientists stress that to date, there's no proven effect on human fertility. As a precaution, experts suggest skipping plastic containers and bottles. especially when heating food and opting for glass, steel, or bamboo alternatives.
New York Post
a day ago
- Health
- New York Post
Plastic in your privates: New microplastics discovery sparking fertility concerns
It's time to talk about the birds, the bees and the PTFEs. They're already in our lungs, livers, kidneys, blood and even our brains. New research out Tuesday in the journal Human Reproduction reveals that microplastics are coming for our baby-makers, too. Advertisement 3 A new study has found a shocking amount of microplastics in semen and ovaries — experts are worried about what this means for fertility. vladimirfloyd – In a disturbing discovery, scientists have detected these tiny particles lurking in semen and ovaries — sparking concern about their impact on fertility and reproductive health. Researchers analyzed the follicular and seminal fluid of 29 women and 22 men and found microplastics in 55% of male samples and 69% of female ones. Advertisement 'Previous studies had already shown that microplastics can be found in various human organs,' lead researcher Dr. Emilio Gomez-Sanchez said in a statement as the research was presented at the European Society of Human Reproduction and Embryology's annual meeting. 'As a result, we weren't entirely surprised to find microplastics in fluids of the human reproductive system, but we were struck by how common they were.' 3 Researchers analyzed the follicular and seminal fluid of 29 women and 22 men and found microplastics in 55% of male samples and 69% of female ones. Vera Kuttelvaserova – The worst offenders in semen were PTFEs — the chemical name of Teflon — which were identified in 41% of the samples. Advertisement Trailing behind were polystyrene, which is like styrofoam (14%); polyethylene terephthalate, in the polyester family (9%); polyamide or nylon (5%) and polyurethane, in coatings and foams (5%). The impact these microplastics — defined as plastic particles under 5 millimeters in size — have on reproductive health is unclear, but it's unlikely to be anything good. 'What we know from animal studies is that in the tissues where microplastics accumulate, they can induce inflammation, free radical formation, DNA damage, cellular senescence and endocrine disruptions,' Gomez-Sanchez said. Advertisement 'It's possible they could impair egg or sperm quality in humans, but we don't yet have enough evidence to confirm that.' While he cautions against going into a full-blown panic, the findings are concerning — especially as the US grapples with a fertility crisis. 'There's no need for alarm at this point. Microplastics are just one of many elements that may play a role in fertility,' 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 minimize our intake.' 3 The worst offenders in semen were PTFEs — the chemical name of Teflon — which were identified in 41% of the samples. Studio Romantic – A separate team in Italy recently found microplastics in the ovarian follicular fluid of 14 out of 18 women they studied. Lead author Luigi Montano said the findings were 'very alarming,' noting that his previous research suggested that microplastics lower sperm count and quality. Advertisement These tiny particles also seem to be present in the uterus and placenta, as well as human testicles, in shockingly high amounts. There are two main ways human bodies get contaminated with microplastics: by breathing them in the air or by eating them in food. Unfortunately, they are ubiquitous, with estimates that 10 million to 40 million metric tons are let loose into the environment every year. Advertisement Researchers have found that people consume about 5 grams a week, or enough to fill a soup spoon. In a year, that's about 250 grams — described as a 'heaped dinner plate's worth.'
