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Follitropin alfa

Manuel Fernández-Sánchez, Hana Visnova, Albert Yuzpe, Bjarke Mirner Klein, Bernadette Mannaerts, Joan-Carles Arce
RESEARCH QUESTION: Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions? DESIGN: A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123)...
December 23, 2018: Reproductive Biomedicine Online
Amir Lass, Stephen Maxwell Montgomery
No abstract text is available yet for this article.
January 29, 2019: Journal of Medical Economics
Salvatore Gizzo, Marcos Ferrando, Monica Lispi, Claudio Ripellino, Nazarena Cataldo, Klaus Bühler
No abstract text is available yet for this article.
January 29, 2019: Journal of Medical Economics
Ernesto Bosch, Jon Havelock, Fernando Sánchez Martin, Birgitte Buur Rasmussen, Bjarke Mirner Klein, Bernadette Mannaerts, Joan-Carles Arce
RESEARCH QUESTION: To evaluate the immunogenicity of follitropin delta in repeated ovarian stimulation. DESIGN: Controlled, assessor-blind trial in IVF/intracytoplasmic sperm injection patients undergoing repeated cycles of ovarian stimulation (cycles 2 and 3), following initial stimulation with follitropin delta or follitropin alfa (cycle 1) in a preceding randomized trial. In cycles 2 and 3, 513 and 188 women, respectively, were treated as randomized in cycle 1, with dosing based on ovarian response in the previous cycle...
December 14, 2018: Reproductive Biomedicine Online
V Isnard, S Paillet, V Patin, F Lesourd-Pontonnier, M Pasquier-Pelletier, D Dewailly
OBJECTIVES: The main objective of this study was to describe the ovulation rate in patients with polycystic ovary syndrome, treated with ovulation induction/intra-uterine insemination and follitropin alfa by gonadotrophins at a second attempt. METHODS: An observational, national and multicentre study was carried out: 51 French physicians (endocrinologists, gynaecologists) participated. Eligible patients were followed according to the usual clinical practices. The primary endpoint was the number of ovulations (spontaneous or triggered)...
December 17, 2018: Gynecologie, Obstetrique, Fertilite & Senologie
Michaël Grynberg, Claire Murphy, Carole Doré, Laurence Fresneau, Ségolène Paillet, Nicoleta Petrica, Maurel Frédérique, Harinala Ravonimbola
OBJECTIVE: To assess the cost-effectiveness (CE) of the originator follitropin-α (Gonal-F) in patients undergoing a medically assisted reproduction (MAR) program in comparison to its biosimilars Bemfola and Ovaleap in a French context. METHODS: A CE model was developed for France with a National Health Service (NHS) perspective. Clinical, safety, and dosage data were derived from pivotal clinical trials that compared Gonal-F to Ovaleap and Bemfola. Costs pertaining to drugs, hospitalizations, specialist visits, and examinations were retrieved from the French Programme de Médicalisation des Systèmes d'Information (PMSI) hospital database, literature review, and French clinical experts using 2017 Euro tariffs...
November 21, 2018: Journal of Medical Economics
Nadezda Abramova, Julie Hubbard, Joan Schertz, Emilia Richter
INTRODUCTION: Recombinant human luteinizing hormone (r-hLH) is used in a fixed-ratio combination with recombinant human follicle-stimulating hormone (r-hFSH) for the stimulation of follicular development. OBJECTIVE: The objective of this article was to conduct a review of safety data to evaluate the risks of r-hFSH/r-hLH treatment. METHODS: Data were retrieved from the Global Safety Database (Merck KGaA, Darmstadt, Germany) including reports from healthcare professionals, patients, health authorities, clinical trials, non-interventional studies, and the literature...
October 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Salvatore Gizzo, Marcos Ferrando, Monica Lispi, Claudio Ripellino, Nazarena Cataldo, Klaus Bühler
BACKGROUND/OBJECTIVE: Although biosimilar drugs may be cheaper to purchase than reference biological products, they may not be the most cost-effective treatment to achieve a desired outcome. The analysis reported here compared the overall costs to achieve live birth using the reference follitropin alfa (GONAL-f) or a biosimilar (Ovaleap) in Spain, Italy and Germany. METHODS: Patient and treatment data was obtained from published sources; assisted-reproductive technology, gonadotropin, follow-up and adverse-event-related costs were calculated from tariffs and reimbursement frameworks for each country...
August 31, 2018: Journal of Medical Economics
Helen Saunders, Laura de la Fuente Bitaine, Chriss Eftekhar, Colin M Howles, Johanna Glaser, Tina Hoja, Pablo Arriagada
OBJECTIVE: The main objective of this user experience testing study was to evaluate the impact of human factors on the use of a disposable pen containing follitropin alfa by patients and nurses with special focus on the convenience, safety and ease of use, in different types of stimulation protocols. METHODS: Infertile women trying to conceive, and specialist nurses were recruited across 6 European countries. In total 18 patients and 19 nurses took part in the testing, which included both nurse-patient pairings and in-depth interviews...
June 2018: Expert Opinion on Drug Delivery
Hideyuki Ikenaga, Yudai Tanaka, Masahide Shiotani, Daniela Rogoff, Shin Shimizu, Osamu Ishihara, Yoshiaki Sato, Yoshiharu Morimoto, Aisaku Fukuda, Kohzo Aisaka, Koji Yoshida, Naoki Hayashi, Hirotsugu Oku, Yuji Abe, Atsushi Haruki, Motoharu Ishikawa, Takeshi Kuramoto
Aim: Outside of Japan, recombinant-human chorionic gonadotropin (r-hCG) is widely used for the induction of final follicular maturation and early luteinization in women undergoing ovulation induction; whereas in Japan, urine-derived hCG (u-hCG) is predominantly used. The primary objective of this study was to demonstrate the non-inferiority of r-hCG to u-hCG for ovulation induction, as assessed by the ovulation rate. Methods: This was an open-label, parallel-group, randomized, multicenter, phase III trial in Japanese women with anovulation or oligo-ovulation secondary to hypothalamic-pituitary dysfunction or polycystic ovary syndrome, undergoing ovulation induction with recombinant-human follicle-stimulating hormone...
January 2017: Reproductive Medicine and Biology
Mary Mahony, Andrea Dwyer, Raschelle Barkume, Allison Strochlic, Fabien Jeannerot, Thomas Stüdeli
OBJECTIVES: The multi-dose, pre-filled GONAL-f® RFF Redi-ject® (follitropin alfa injection) pen injector was updated following feedback on user experience and pen functionality, as part of a continuous assessment program. Human-factors engineering (HFE) evaluations were conducted to confirm that the updated pen injector could be used by intended users to safely and effectively perform critical tasks identified by the risk-management plan. METHODS: Five rounds of formative evaluation and a simulated-use summative evaluation of the pen injector, instructions for use (IFU), and training video were conducted by HFE specialists or the intended users of the pen injector...
January 2018: Expert Opinion on Drug Delivery
Ch O Jacke, F Wild
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period...
December 15, 2016: Versicherungsmedizin
Renato Mastrangeli, Abhijeet Satwekar, Francesca Cutillo, Cinzia Ciampolillo, Wolf Palinsky, Salvatore Longobardi
Recombinant human follicle-stimulating hormone (r-hFSH) is widely used in fertility treatment. Although biosimilar versions of r-hFSH (follitropin alfa) are currently on the market, given their structural complexity and manufacturing process, it is important to thoroughly evaluate them in comparison with the reference product. This evaluation should focus on how they differ (e.g., active component molecular characteristics, impurities and potency), as this could be associated with clinical outcome. This study compared the site-specific glycosylation profile and batch-to-batch variability of the in-vivo bioactivity of Bemfola, a biosimilar follitropin alfa, with its reference medicinal product GONAL-f...
2017: PloS One
P Humaidan, W Chin, D Rogoff, T D'Hooghe, S Longobardi, J Hubbard, J Schertz
No abstract text is available yet for this article.
July 1, 2017: Human Reproduction
Charalampos Siristatidis, Konstantinos Dafopoulos, Nikolas Christoforidis, George Anifandis, Vasileios Pergialiotis, Nikolaos Papantoniou
Recombinant DNA technologies have produced Corifollitropin alfa (CFa) used during IVF/ICSI in order to keep the circulating FSH levels above the threshold necessary to support multi-follicular growth for a week. In this prospective case-control study, we compared 70 participants treated with 150 μg CFa combined with 150 IU of follitropin beta (study group) with 70 subfertile participants with matching baseline characteristics, conforming with the same inclusion criteria and treated with an antagonist protocol using follitropin beta (control group)...
December 2017: Gynecological Endocrinology
Wolfgang Koechling, Daniel Plaksin, Glenn E Croston, Janni V Jeppesen, Kirsten T Macklon, Claus Yding Andersen
Recombinant FSH proteins are important therapeutic agents for the treatment of infertility, including follitropin alfa expressed in Chinese Hamster Ovary (CHO) cells and, more recently, follitropin delta expressed in the human cell line PER.C6. These recombinant FSH proteins have distinct glycosylation, and have distinct pharmacokinetic and pharmacodynamic profiles in women. Comparative experiments demonstrated that follitropin delta and follitropin alfa displayed the same in vitro potency at the human FSH receptor, but varied in their pharmacokinetics in mouse and rat...
July 2017: Endocrine Connections
Joan Schertz, Hilary Worton
OBJECTIVES: We aimed to evaluate the overall impressions of learning and subsequent use of the redesigned GONAL-f® (follitropin alfa) pen injector by women with recent or current infertility requiring assisted reproductive technologies (ART) or in vitro fertilization (IVF). METHODS: This was a simulated-use study including 86 women with infertility and 30 fertility nurses. Nurses trained the women on the use of the redesigned pen. The opinions of the women on the pen injector were collected during a questionnaire interview...
April 2017: Expert Opinion on Drug Delivery
P Humaidan, W Chin, D Rogoff, T D'Hooghe, S Longobardi, J Hubbard, J Schertz
STUDY QUESTION: How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH (follitropin alfa plus lutropin alfa; r-hFSH/r-hLH) compare with that of r-hFSH monotherapy for controlled ovarian stimulation (COS) in patients with poor ovarian response (POR)? SUMMARY ANSWER: The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable...
March 1, 2017: Human Reproduction
Salvatore Gizzo, Juan A Garcia-Velasco, Franca Heiman, Claudio Ripellino, Klaus Bühler
OBJECTIVES: To perform a cost-effectiveness evaluation comparing the originator follitropin alfa (Gonal-f(®)) to the biosimilar (Bemfola(®)) in the Italian and Spanish contexts, with an assessment of the German and UK backgrounds. METHODS: Starting from the study by Rettenbacher et al, a cost-effectiveness model was developed in the Italian and Spanish contexts. Clinical data on subjects, doses of gonadotropin, pregnancies, live-born children, and ovarian hyperstimulation syndrome were used to feed the model...
2016: International Journal of Women's Health
Anders Nyboe Andersen, Scott M Nelson, Bart C J M Fauser, Juan Antonio García-Velasco, Bjarke M Klein, Joan-Carles Arce
OBJECTIVE: To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antimüllerian hormone (AMH) and body weight, with conventional follitropin alfa dosing for ovarian stimulation in women undergoing IVF. DESIGN: Randomized, multicenter, assessor-blinded, noninferiority trial (ESTHER-1). SETTING: Reproductive medicine clinics. PATIENT(S): A total of 1,329 women (aged 18-40 years)...
February 2017: Fertility and Sterility
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