keyword
https://read.qxmd.com/read/38486276/efficacy-and-safety-of-follitropin-delta-for-ovarian-stimulation-in-vitro-fertilization-intracytoplasmic-sperm-injection-cycles-a-systematic-review-with-meta-analysis
#1
REVIEW
Stefano Palomba, Donatella Caserta, Paolo Emanuele Levi-Setti, Andrea Busnelli
BACKGROUND: Follitropin delta is a novel recombinant follicle stimulating hormone preparation uniquely expressed in a human fetal retinal cell line by recombinant DNA technology. To date, no systematic review was available about the safety and the efficacy of the follitropin delta. The objective of this study was systematically reviewing the available literature and to provide updated evidence regarding the efficacy-safety profile of follitropin delta when compared to other gonadotropin formulations for ovarian stimulation in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles...
March 14, 2024: Journal of Ovarian Research
https://read.qxmd.com/read/38299472/dose-accuracy-of-the-follitropin-alfa-pen-injector-2-0-the-follitropin-alfa-lutropin-alfa-2-1-combination-pen-injector-2-0-and-the-choriogonadotropin-alfa-pen-injector-1-0-used-for-fertility-treatment
#2
JOURNAL ARTICLE
Evelyn Cottell, Damien Michalet, Monica Lispi, Thiago Dantas Araujo, Ralf Gleixner, Salvatore Longobardi, Thomas D'Hooghe
BACKGROUND: This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors. RESEARCH DESIGN AND METHODS: Set doses (Vset ) for three dose dial settings (minimum dose [Vmin ], midpoint dose [Vmid ] and maximum dose [Vmax ] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single Vset for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed...
February 1, 2024: Expert Opinion on Drug Delivery
https://read.qxmd.com/read/38045504/erratum-clinical-outcomes-in-patients-receiving-originator-follitropin-alfa-and-follitropin-alfa-biosimilars-in-real-world-clinical-practice-a-retrospective-study
#3
(no author information available yet)
[This corrects the article on p. 148 in vol. 16, PMID: 37547084.].
2023: Journal of Human Reproductive Sciences
https://read.qxmd.com/read/37903465/effects-of-low-lh-serum-levels-on-oocyte-retrieval-fertilization-rate-and-embryo-quality-during-controlled-ovarian-stimulation-results-from-a-prospective-cohort-analysis
#4
JOURNAL ARTICLE
Jessica Dragotto, Giovanni Buzzaccarini, Andrea Etrusco, Antonio Simone Laganà, Renato Venezia, Sanja Terzic, Miriam Dellino, Chrysoula Margioula-Siarkou, Vittorio Unfer, Bianca Bianco, Paolo Casadio, Giovanni Bracchitta
OBJECTIVES: Luteinizing hormone plays a key role in normal follicular development and oocyte maturation in controlled ovarian stimulation. Luteinizing hormone stimulates the proliferation and differentiation of theca cells for the secretion of androgens, synergistically increasing estrogen production. This study aimed to investigate the effects of low luteinizing hormone concentrations on oocyte retrieval, fertilization and embryo development in patients undergoing in vitro fertilization/intracytoplasmic sperm injection...
October 30, 2023: Gynecologic and Obstetric Investigation
https://read.qxmd.com/read/37727455/fine-tuning-the-dose-of-recombinant-human-follicle-stimulating-hormone-alfa-to-individualize-treatment-in-ovulation-induction-and-ovarian-stimulation-cycles-a-real-world-database-analysis
#5
JOURNAL ARTICLE
Anne E Martini, Stephanie Beall, G David Ball, Brooke Hayward, Thomas D'Hooghe, Mary C Mahony, Fabricio Collares, Allison B Catherino
INTRODUCTION: Fine-tuning of injectable gonadotropin doses during ovulation induction (OI) or ovarian stimulation (OS) treatment cycles with the aim of using doses low enough to minimize the risk of excessive ovarian response while maintaining optimal efficacy may be facilitated by using an adjustable-dose pen injector. We examined the incidence and magnitude of individualized gonadotropin dose adjustments made during cycles of OI or OS, followed by either timed intercourse or intrauterine insemination, with or without oral medications, and assessed the relationship between patient characteristics and dosing changes using real-world evidence...
2023: Frontiers in Endocrinology
https://read.qxmd.com/read/37547576/the-effect-of-follitropin-alfa-in-controlled-ovarian-stimulation-protocol-for-in-vitro-fertilization-cycles
#6
JOURNAL ARTICLE
Novita Prasetiawati, Ayu Mulia Sundari, Agus Supriyadi, Hadi Sjarbaini, Sudirmanto Tarigan, Gde Suardana, Gangsar Pariyanti, Deana Rosaria Indah, Euis Purwatyningsih, Anom Bowolaksono
BACKGROUND: Follitropin alfa (FA) is one of the most widely used exogenous gonadotropins in both agonist and antagonist protocols for controlled ovarian stimulation (COS) and in vitro fertilization (IVF). However, reports of its effectiveness are limited, particularly in terms of its impact on overall IVF outcomes and ovarian hyperstimulation syndrome (OHSS). Therefore, in this study, FA competency was investigated by evaluating its effect on IVF outcomes and OHSS, administering agonist and antagonist COS protocols...
2023: Journal of Reproduction & Infertility
https://read.qxmd.com/read/37547084/clinical-outcomes-in-patients-receiving-originator-follitropin-alfa-and-follitropin-alfa-biosimilars-in-real-world-clinical-practice-a-retrospective-study
#7
JOURNAL ARTICLE
Nayana Hitesh Patel, Niket H Patel, Molina Niket Patel, Harsha K Bhadarka, Kairavi Sunilkumar Vyas
BACKGROUND: Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f® ) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug. AIMS: To compare the ART outcomes in patients receiving originator follitropin (Gonal-f® ) and its biosimilars in clinical setting. SETTINGS AND DESIGN: Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed...
2023: Journal of Human Reproductive Sciences
https://read.qxmd.com/read/37496043/correction-biosimilar-recombinant-follitropin-alfa-preparations-versus-the-reference-product-gonal-f%C3%A2-in-couples-undergoing-assisted-reproductive-technology-treatment-a-systematic-review-and-meta-analysis
#8
Christos A Venetis, Christoph Helwig, Ben W Mol, Su Jen Chua, Salvatore Longobardi, Raoul Orvieto, Monica Lispi, Ashleigh Storr, Thomas D'Hooghe
No abstract text is available yet for this article.
July 26, 2023: Reproductive Biology and Endocrinology: RB&E
https://read.qxmd.com/read/36828193/randomized-controlled-trials-do-not-always-fit-the-purpose-a-science-based-response-to-venetis-and-mol-s-editorial-on-biosimilars-of-follitropin-alfa
#9
EDITORIAL
Fernando de Mora, Colin M Howles
No abstract text is available yet for this article.
February 22, 2023: Drug Discovery Today
https://read.qxmd.com/read/36672987/a-narrative-review-discussing-the-efficiency-of-personalized-dosing-algorithm-of-follitropin-delta-for-ovarian-stimulation-and-the-reproductive-and-clinical-outcomes
#10
REVIEW
Bogdan Doroftei, Ovidiu-Dumitru Ilie, Nicoleta Anton, Olivia-Andreea Marcu, Ioana-Sadyie Scripcariu, Ciprian Ilea
Background: Follitropin delta is the third recombinant human follicle-stimulating hormone (r-hFSH) expressed in a host cell line of human fetal retinal origin that currently emphasizes that the actual tendency of administration is a personalized dosing algorithm based on the anti-Müllerian hormone (AMH) and body mass index (BMI) for ovarian stimulation. Methods: In this context, we aimed, in the present manuscript, to gather all available data published between 2018-2022 regarding the co-administration and administration of follitropin delta and the clinical outcomes reported following an in vitro fertilization (IVF)...
January 4, 2023: Diagnostics
https://read.qxmd.com/read/36534054/an-updated-meta-analysis-comparing-the-efficacy-and-safety-of-biosimilar-medicinal-products-to-the-original-follitropin-alfa
#11
JOURNAL ARTICLE
Maria C Budani, Stefania Fensore, Marco DI Marzio, Gian M Tiboni
INTRODUCTION: The aim of this study was to provide an updated meta-analysis assessing the therapeutic equivalence between follitropin alfa biosimilars and the reference medication in women undergoing assisted reproductive technologies (ART). EVIDENCE ACQUISITION: The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) for binary outcomes and the mean difference (MD) for continuous outcomes along with the corresponding 95% confidence intervals (CI) by using a random effects model...
December 19, 2022: Minerva obstetrics and gynecology
https://read.qxmd.com/read/36332833/biosimilars-versus-the-originator-of-follitropin-alfa-randomized-controlled-trials-are-still-the-best-way-to-evaluate-their-comparative-effectiveness-in-assisted-reproduction
#12
EDITORIAL
Christos A Venetis, Ben W Mol
Biosimilars of follitropin alfa have been introduced in many countries as more affordable alternatives to the reference product for patients undergoing ovarian stimulation for assisted reproductive technology cycles. A recent meta-analysis, by reviewing available evidence originating from randomised controlled trials, has shown that based on the best available evidence, biosimilars of follitropin alfa are associated with lower live birth, ongoing and clinical pregnancy rates compared to the reference product...
February 2023: Drug Discovery Today
https://read.qxmd.com/read/36195924/comparative-clinical-outcome-following-individualized-follitropin-delta-dosing-in-chinese-women-undergoing-ovarian-stimulation-for-in-vitro-fertilization-intracytoplasmic-sperm-injection
#13
RANDOMIZED CONTROLLED TRIAL
Rui Yang, Yunshan Zhang, Xiaoyan Liang, Xueru Song, Zhaolian Wei, Jianqiao Liu, Yezhou Yang, Jichun Tan, Qingxue Zhang, Yingpu Sun, Wei Wang, Weiping Qian, Lei Jin, Shuyu Wang, Yang Xu, Jing Yang, Marie Goethberg, Bernadette Mannaerts, Wen Wu, Zugeng Zheng, Jie Qiao
BACKGROUND: To compare the efficacy and safety of follitropin delta in its individualized fixed-dose regimen with follitropin alfa in a conventional adjustable dosing regimen in Chinese women.  METHODS: This was a subgroup analysis of the randomized, multi-center, assessor-blind, non-inferiority trial (GRAPE) including 759 Chinese women (aged 20-40 years) recruited in 16 reproductive medicine clinics in China. Women were randomized in a 1:1 ratio to be treated with either follitropin delta dose based on anti-Müllerian hormone (AMH) and body weight or conventional dosing with follitropin alfa following a gonadotropin-releasing hormone (GnRH) antagonist protocol...
October 4, 2022: Reproductive Biology and Endocrinology: RB&E
https://read.qxmd.com/read/35998407/superovulation-of-high-producing-holstein-lactating-dairy-cows-with-human-recombinant-fsh-and-hmg
#14
JOURNAL ARTICLE
Alireza Khodadadi, Amir Niasari-Naslaji, Darab Nikjou, Behrouz Mohammadi
Superovulation of high-producing dairy cows is a challenging subject in dairy farms with respect to the cost, dose and type of gonadotropin. The objectives of this study were to compare three gonadotropin products: Folltropin-V® (highly purified FSH with porcine origin), Cinnal-f® (recombinant human FSH) and Menotropins® (hMG) for superovulation in high-producing Holstein lactating dairy cows and to investigate the pregnancy outcomes achieved following transferring embryos recovered from donors treated with different gonadotropins...
August 10, 2022: Theriogenology
https://read.qxmd.com/read/35743204/comparative-assessment-of-the-structural-features-of-originator-recombinant-human-follitropin-alfa-versus-recombinant-human-follitropin-alfa-biosimilar-preparations-approved-in-non-european-regions
#15
JOURNAL ARTICLE
Lucio Manzi, Nunzio Sepe, Walter Migliaccio, Ludovica Lanzoni, Luisa Iozzino, Fabrizia D'Angelo, Lucia Colarusso, Susana Montenegro, Angelo Palmese, Thomas D'Hooghe, Alfredo Ulloa-Aguirre, Yulia Koloda, Monica Lispi
Although the full primary structures of the alfa and beta subunits of reference r-hFSH-alfa and its biosimilars are identical, cell context-dependent differences in the expressing cell lines and manufacturing process can lead to variations in glycosylation profiles. In the present study, we compared the structural features of reference r-hFSH-alfa with those of five biosimilar preparations approved in different global regions outside Europe (Primapur® , Jin Sai Heng® , Follitrope® , Folisurge® , and Corneumon® ) with respect to glycosylation, macro- and microheterogeneity, and other post-translational modifications and higher order structure...
June 17, 2022: International Journal of Molecular Sciences
https://read.qxmd.com/read/35490965/overlapping-biosimilar-and-originator-follitropin-alfa-preparations-how-much-closer-can-they-get
#16
JOURNAL ARTICLE
Fernando de Mora, Colin M Howles
Unfounded skepticism relating to biosimilars, arising from the assertion that they are not molecularly identical to their original counterpart, fails to acknowledge that no biological medicine, including Gonal-f® (from Merck Serono) is identical to itself. Molecular differences between the biosimilar and the reference medicines are irrelevant and clinically undetectable as long as they are contained within the accepted variability for the original medicine. Accordingly, the minor differences in 'ongoing pregnancy rate' and 'live birth' rate reported in a recent meta-analysis of biosimilars of Gonal-f® from Chua et al...
August 2022: Drug Discovery Today
https://read.qxmd.com/read/34980816/-pharmacological-profile-clinical-efficacy-and-safety-of-follitropin-delta-produced-by-recombinant-dna-technology-in-a-human-cell-line-rekovelle-%C3%A2-pen-for-s-c-injection-12%C3%A2-%C3%AE-g-36%C3%A2-%C3%AE-g-72%C3%A2-%C3%AE-g
#17
JOURNAL ARTICLE
Yoshiharu Abe, Yasushi Ozeki
Follitropin Delta (Rekovellle Subcutaneous Injection 12 μg/ 36 μg/72 μg Pen) is a recombinant human follicle-stimulating hormone (rFSH) developed by Ferring Pharmaceuticals Co., Ltd. Because human follicle-stimulating hormone (FSH) gene is incorporated into a human-derived cell line (human embryonic retinoblastoma: PER.C6), the Follitropin Delta is produced with having α2.3 and α2.6 linked sialic acid sugar chain which is similar to natural human FSH. Containing these two types of sialic acids linkage, similar blood dynamics with natural FSH can be expected due to the reduction of hepatic clearance...
2022: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://read.qxmd.com/read/34977459/comparing-a-biosimilar-follitropin-alfa-cinnal-f%C3%A2-with-gonal-f%C3%A2-in-women-undergoing-ovarian-stimulation-an-rct
#18
JOURNAL ARTICLE
Batool Hossein Rashidi, Khashayar Sayyari, Ramin Heshmat, Saeid Amanpour, Ensieh Shahrokh Tehraninejad, Masoumeh Masoumi, Farhang Rezaei
BACKGROUND: Advances in recombinant DNA technology led to the development of recombinant follitropin alfa. Recombinant human follicle-stimulating hormone products are used to stimulate follicular maturation. OBJECTIVE: To compare the efficacy and safety of a biosimilar-candidate recombinant human follicle-stimulating hormone (Cinnal-fⓇ; CinnaGen, Iran) with the reference product (Gonal-fⓇ; Merck Serono, Germany) in women undergoing ovarian stimulation for intracytoplasmic sperm injection (ICSI)...
November 2021: International Journal of Reproductive Biomedicine (Yazd, Iran)
https://read.qxmd.com/read/34937512/ivf-protocol-efficacy-in-women-with-expected-suboptimal-response-depending-on-ovary-stimulation-mode
#19
RANDOMIZED CONTROLLED TRIAL
K V Ob'edkova, I Y Kogan, V C Muller, N I Tapilskaya, I O Krikhely, L Kh Dzhemlikhanova, Z K Abdulkadirova, I D Mekina, E A Lesik, E A Komarova, M A Ishchuk, A M Gzgzian
INVESTIGATION OBJECTIVE: IVF protocol efficacy estimation in women with expected suboptimal response depending on ovary stimulation mode. MATERIALS AND TECHNIQUE: A randomized controlled study embracing results of 51 IVF cycle in women with ovary suboptimal response. The suboptimal response prognostic analysis was performed basing on ≤9 oocyte cumulus complexes obtained in previous IVF programs, the presence of no less than 5-9 antral follicles in both oocytes and amount of anti-Mullerian Hormone ≥0,8 ng/mL...
2021: Gynecological Endocrinology
https://read.qxmd.com/read/34895264/comparison-of-the-number-of-oocytes-obtained-after-ovarian-stimulation-between-chinese-and-caucasian-women-undergoing-in-vitro-fertilization-using-a-standardized-stimulation-regime
#20
COMPARATIVE STUDY
Jennifer K Y Ko, Andrew Kan, Peter Leung, Vivian C Y Lee, Raymond H W Li, William Ledger, Ernest H Y Ng
BACKGROUND: In vitro fertilization (IVF) is a well-established method to treat various causes of infertility. Some previous retrospective studies suggested a lower ovarian response in Asian women compared to Caucasian women. However, the ovarian stimulation regimens were not standardized, potentially confounding the findings. The objective of this study is to compare the number of oocytes obtained after ovarian stimulation between Chinese and Caucasian women undergoing IVF using a standardized stimulation regimen...
December 11, 2021: Journal of Ovarian Research
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