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https://www.readbyqxmd.com/read/30341677/safety-of-follitropin-alfa-lutropin-alfa-for-stimulation-of-follicular-development
#1
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
https://www.readbyqxmd.com/read/30113238/a-cost-effectiveness-modeling-evaluation-comparing-a-biosimilar-follitropin-alfa-preparation-with-its-reference-product-for-live-birth-outcome-in-germany-italy-and-spain
#2
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
https://www.readbyqxmd.com/read/29595399/functionality-of-a-novel-follitropin-alfa-pen-injector-results-from-human-factor-interactions-by-patients-and-nurses
#3
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
https://www.readbyqxmd.com/read/29259450/phase-iii-trial-comparing-the-efficacy-and-safety-of-recombinant-or-urine-derived-human-chorionic-gonadotropin-for-ovulation-triggering-in-japanese-women-diagnosed-with-anovulation-or-oligo-ovulation-and-undergoing-ovulation-induction-with-follitropin-alfa
#4
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
https://www.readbyqxmd.com/read/29198148/us-human-factors-engineering-evaluation-of-an-updated-follitropin-alfa-pen-injector-gonal-f%C3%A2-rff-redi-ject%C3%A2-and-instructions-for-use
#5
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
https://www.readbyqxmd.com/read/29144113/-can-we-transfer-the-mechanisms-of-the-generics-market-to-biosimilars
#6
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
https://www.readbyqxmd.com/read/28880909/in-vivo-biological-activity-and-glycosylation-analysis-of-a-biosimilar-recombinant-human-follicle-stimulating-hormone-product-bemfola-compared-with-its-reference-medicinal-product-gonal-f
#7
COMPARATIVE STUDY
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
https://www.readbyqxmd.com/read/28541398/efficacy-and-safety-of-follitropin-alfa-lutropin-alfa-in-art-a-randomized-controlled-trial-in-poor-ovarian-responders
#8
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
https://www.readbyqxmd.com/read/28508691/corifollitropin-alfa-compared-with-follitropin-beta-in-gnrh-antagonist-ovarian-stimulation-protocols-in-an-unselected-population-undergoing-ivf-icsi
#9
COMPARATIVE STUDY
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
https://www.readbyqxmd.com/read/28450423/comparative-pharmacology-of-a-new-recombinant-fsh-expressed-by-a-human-cell-line
#10
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
https://www.readbyqxmd.com/read/28140682/patient-evaluation-of-the-redesigned-follitropin-alfa-pen-injector
#11
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
https://www.readbyqxmd.com/read/28137754/efficacy-and-safety-of-follitropin-alfa-lutropin-alfa-in-art-a-randomized-controlled-trial-in-poor-ovarian-responders
#12
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/27994486/a-cost-effectiveness-evaluation-comparing-originator-follitropin-alfa-to-the-biosimilar-for-the-treatment-of-infertility
#13
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
https://www.readbyqxmd.com/read/27912901/individualized-versus-conventional-ovarian-stimulation-for-in-vitro-fertilization-a-multicenter-randomized-controlled-assessor-blinded-phase-3-noninferiority-trial
#14
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/27636195/dose-accuracy-of-the-redesigned-follitropin-alfa-pen-injector-for-infertility-treatment
#15
COMPARATIVE STUDY
Fabien Jeannerot, Alexandra Cusin, Joan Schertz
OBJECTIVES: The prefilled, multi-dose follitropin alfa (GONAL-f®) pen injector was redesigned based upon user feedback, to improve pen functionality. The dose information display was altered with the intention of improving readability and the dosing mechanism hardware was modified to increase robustness. The dose accuracy of the redesigned pen injector was evaluated under different conditions and after handling processes. METHODS: Three studies investigated the dose accuracy of the three presentations (300, 450 and 900 IU) of the redesigned pen injector according to the ISO 11608-1:2012/2014 standard...
December 2016: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27581117/economic-evaluation-of-three-frequently-used-gonadotrophins-in-assisted-reproduction-techniques-in-the-management-of-infertility-in-the-netherlands
#16
Vassilis Fragoulakis, Chris P Pescott, Jesper M J Smeenk, Evert J P van Santbrink, G Jur E Oosterhuis, Frank J M Broekmans, Nikos Maniadakis
BACKGROUND AND OBJECTIVE: Subfertility represents a multidimensional problem associated with significant distress and impaired social well-being. In the Netherlands, an estimated 50,000 couples visit their general practitioner and 30,000 couples seek medical specialist care for subfertility. We conducted an economic evaluation comparing recombinant human follicle-stimulating hormone (follitropin alfa, r-hFSH, Gonal-F® ) with two classes of urinary gonadotrophins-highly purified human menopausal gonadotrophin (hp-HMG, Menopur® ) and urinary follicle-stimulating hormone (uFSH, Fostimon® )-for ovarian stimulation in women undergoing in vitro fertilization (IVF) treatment in the Netherlands...
December 2016: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/27342604/xm17-follitropin-alfa-ovaleap-%C3%A2-a-review-in-reproductive-endocrine-disorders
#17
REVIEW
Sheridan M Hoy
The subcutaneous recombinant human follicle-stimulating hormone XM17 follitropin alfa (Ovaleap(®)) is approved in the EU as a biosimilar of follitropin alfa (Gonal-f(®)) for use in all indications for which the reference product is approved, including as a multifollicular stimulant in women undergoing superovulation for assisted reproductive technology (ART) treatment. In a nonblind, phase I study in healthy female volunteers, the pharmacokinetic profile of XM17 follitropin alfa was bioequivalent to that of reference follitropin alfa following single dosing...
August 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27329677/usability-engineering-study-in-the-european-union-of-a-redesigned-follitropin-alfa-pen-injector-for-infertility-treatment
#18
Fabien Jeannerot, Thomas Stüdeli, Lisa Gunther-LaVergne, David Hirning, Joan Schertz
OBJECTIVES: The prefilled, multidose, GONAL-f (®) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesigned pen injector could be used by the intended users to safely and effectively deliver follitropin alfa. METHODS: Formative and summative usability engineering evaluations of the pen injector, training and instructions for use (IFU) were conducted...
September 2016: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27287439/safety-and-efficacy-of-ovaleap%C3%A2-recombinant-human-follicle-stimulating-hormone-for-up-to-3%C3%A2-cycles-in-infertile-women-using-assisted-reproductive-technology-a-phase-3-open-label-follow-up-to-main-study
#19
MULTICENTER STUDY
Thomas Strowitzki, Waldemar Kuczynski, Arnd Mueller, Peter Bias
BACKGROUND: Ovaleap® (follitropin alfa), a recombinant human follicle-stimulating hormone intended for use in controlled ovarian stimulation in women undergoing assisted reproductive technologies (ART), showed therapeutic equivalence to Gonal-f® in a multinational, multicenter, randomized, controlled, assessor-blind phase 3 Main Study. The current study examined safety, including immunogenicity, and efficacy of Ovaleap® in an open-label, uncontrolled, follow-up treatment period of up to 2 additional treatment cycles in patients who did not become pregnant in the phase 3 Main Study...
June 10, 2016: Reproductive Biology and Endocrinology: RB&E
https://www.readbyqxmd.com/read/26991659/when-the-right-drug-should-be-left-prenatal-drug-exposure-and-heterotaxy-syndrome
#20
Nicole R van Veenendaal, Cynthia D J Kusters, Roelof-Jan Oostra, Jorieke E H Bergman, Jan-Maarten Cobben
BACKGROUND: Recent studies reported an association between prenatal propylthiouracil exposure and birth defects, including abnormal arrangement across the left-right body axis, suggesting an association with heterotaxy syndrome. METHODS: This case-control and case-finding study used data from 1981 to 2013 from the EUROCAT birth defect registry in the Northern Netherlands. First, we explored prenatal exposures in heterotaxy syndrome (cases) and Down syndrome (controls)...
July 2016: Birth Defects Research. Part A, Clinical and Molecular Teratology
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