Lunenfeld B, Bilger W, Longobardi S, Alam V, D’Hooghe T, Sunkara SK. The Development of Gonadotropins for Clinical Use in the Treatment of Infertility [Internet]. Front Endocrinol. 2019;10:429. https://doi.org/10.3389/fendo.2019.00429.

Article  Google Scholar 

Lunenfeld B. Gonadotropin stimulation: past, present and future. Reprod Med Biol [Internet]. 2012;11:11–25. https://doi.org/10.1007/s12522-011-0097-2.

Article  CAS  PubMed  Google Scholar 

Niederberger C, Pellicer A, Cohen J, Gardner DK, Palermo GD, O’Neill CL, et al. Forty years of IVF. Fertil Steril [Internet]. 2018;110:185-324.e5. https://doi.org/10.1016/j.fertnstert.2018.06.005.

Article  PubMed  Google Scholar 

Dias J, Ulloa-Aguirre A. New human follitropin preparations: how glycan structural differences may affect biochemical and biological function and clinical effect. Front Endocrinol (Lausanne). 2021;12:636038.

Article  PubMed  Google Scholar 

De Leo V, Musacchio MC, Di Sabatino A, Tosti C, Morgante G, Petraglia F. Present and future of recombinant gonadotropins in reproductive medicine [Internet]. Curr Pharm Biotechnol. 2012;13(3):379–91. http://www.eurekaselect.com/node/76486/article. Accessed 1 Mar 2024.

Sharara FI, McClamrock HD. Differences in in vitro fertilization (IVF) outcome between white and black women in an inner-city, university-based IVF program. Fertil Steril. 2000;73:1170–3.

Article  CAS  PubMed  Google Scholar 

Purcell K, Schembri M, Frazier LM, Rall MJ, Shen S, Croughan M, et al. Asian ethnicity is associated with reduced pregnancy outcomes after assisted reproductive technology. Fertil Steril. 2007;87:297–302.

Article  PubMed  Google Scholar 

Huddleston HG, Rosen MP, Lamb JD, Modan A, Cedars MI, Fujimoto VY. Asian ethnicity in anonymous oocyte donors is associated with increased estradiol levels but comparable recipient pregnancy rates compared with Caucasians. Fertil Steril. 2010;94:2059–63.

Article  CAS  PubMed  Google Scholar 

Tabbalat AM, Pereira N, Klauck D, Melhem C, Elias RT, Rosenwaks Z. Arabian Peninsula ethnicity is associated with lower ovarian reserve and ovarian response in women undergoing fresh ICSI cycles. J Assist Reprod Genet. 2018;35:331–7.

Article  PubMed  Google Scholar 

Fauser BCJM, Diedrich K, Devroey P. Predictors of ovarian response: progress towards individualized treatment in ovulation induction and ovarian stimulation. Hum Reprod Update. 2008;14:1–14.

Article  CAS  PubMed  Google Scholar 

Nelson SM. Biomarkers of ovarian response: current and future applications. Fertil Steril [Internet]. 2013;99:963–9. https://doi.org/10.1016/j.fertnstert.2012.11.051.

Article  CAS  PubMed  Google Scholar 

La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update [Internet]. 2014;20:124–40. https://doi.org/10.1093/humupd/dmt037.

Article  CAS  PubMed  Google Scholar 

Broekmans FJ, Kwee J, Hendriks DJ, Mol BW, Lambalk CB. A systematic review of tests predicting ovarian reserve and IVF outcome. Hum Reprod Update. 2006;12:685–718.

Article  CAS  PubMed  Google Scholar 

ESHRE Guidelines. Ovarian stimulation for IVF/ICSI. In: Guideline of the European society of human reproduction and embryology (2019) [Internet]. 2019. https://www.google.com/search?q=.+Available+at%3A+https%3A%2F%2F+www.Eshre.Eu%2F-%2FMedia%2FSitecore-Files%2FGuidelines%2FCos%2FEshre-Cos-Guideline_Final%0209102019_.Pdf%3FLa%3DEn%26Hash%3D2316ea35f8afd21c2fb193c33f3bdc272334c901&oq=.+Available+at%3A+http. Accessed 4 Mar 2024.

Koechling W, Plaksin D, Croston GE, Jeppesen J V, Macklon KT, Andersen CY. Comparative pharmacology of a new recombinant FSH expressed by a human cell line. Endocr Connect [Internet]. 2017;6:297–305. https://www.ncbi.nlm.nih.gov/pubmed/28450423. Accessed 1 Mar 2024.

Olsson H, Sandström R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol [Internet]. 2014;54:1299–307. https://doi.org/10.1002/jcph.328.

Article  CAS  PubMed  Google Scholar 

Howles CM. Genetic engineering of human FSH (Gonal-F®). Hum Reprod Update [Internet]. 1996;2:172–91. https://doi.org/10.1093/humupd/2.2.172.

Article  CAS  PubMed  Google Scholar 

Arce J-C, Klein BM, Erichsen L. Using AMH for determining a stratified gonadotropin dosing regimen for IVF/ICSI and optimizing outcomes. In: Seifer DB, Tal R, editors. Anti-Müllerian hormone: biology, role in ovarian function and clinical significance. 1st ed. Nova Science Publishers, Inc; 2016. pp. 83–102.

Bosch E, Nyboe Andersen A, Barri P, García-Velasco JA, de Sutter P, Fernández-Sánchez M, et al. Follicular and endocrine dose responses according to anti-Müllerian hormone levels in IVF patients treated with a novel human recombinant FSH (FE 999049). Clin Endocrinol (Oxf) [Internet]. 2015;83:902–12. https://doi.org/10.1111/cen.12864.

Article  CAS  Google Scholar 

Rose TH, Röshammar D, Erichsen L, Grundemar L, Ottesen JT. Characterisation of Population Pharmacokinetics and Endogenous Follicle-Stimulating Hormone (FSH) Levels After Multiple Dosing of a Recombinant Human FSH (FE 999049) in Healthy Women. Drugs R D [Internet]. 2016;16:165–72. https://doi.org/10.1007/s40268-016-0126-z.

Article  CAS  PubMed  Google Scholar 

Bergandi L, Canosa S, Carosso AR, Paschero C, Gennarelli G, Silvagno F, et al. Human recombinant FSH and its biosimilars: clinical efficacy, safety, and cost-effectiveness in controlled ovarian stimulation for in vitro fertilization. Pharmaceuticals (Basel). 2020;13:136.

Article  CAS  PubMed  Google Scholar 

Suvarna V. Phase IV of drug development. Perspect Clin Res. 2010;1:57–60.

Article  PubMed  PubMed Central  Google Scholar 

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ [Internet]. 2021;372:n71. http://www.bmj.com/content/372/bmj.n71.abstract. Accessed 4 Mar 2024.

Falagas ME, Pitsouni EI, Malietzis GA, Pappas G. Comparison of PubMed, Scopus, Web of Science, and Google Scholar: strengths and weaknesses. FASEB J Off Publ Fed Am Soc Exp Biol. 2008;22:338–42.

CAS  Google Scholar 

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ [Internet]. 2019;366:l4898. http://www.bmj.com/content/366/bmj.l4898.abstract. Accessed 4 Mar 2024.

McGuinness LA, Higgins JPT. Risk-of-bias VISualization (robvis): An R package and Shiny web app for visualizing risk-of-bias assessments. Res Synth Methods [Internet]. 2020;12:55–61. https://doi.org/10.1002/jrsm.1411.

Article  PubMed  Google Scholar 

Nyboe Andersen A, Nelson SM, Fauser BCJM, García-Velasco JA, Klein BM, Arce J-C, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril [Internet]. 2017;107:387-396.e4. https://doi.org/10.1016/j.fertnstert.2016.10.033.

Article  CAS  PubMed  Google Scholar 

Ishihara O, Klein BM, Arce J-C, Kuramoto T, Yokota Y, Mukaida T, et al. Randomized, assessor-blind, antimüllerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril [Internet]. 2021;115:1478–86. https://doi.org/10.1016/j.fertnstert.2020.10.059.

Article  CAS  PubMed  Google Scholar 

Qiao J, Zhang Y, Liang X, Ho T, Huang H-Y, Kim S-H, 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 [Internet]. 2021;36:2452–62. https://doi.org/10.1093/humrep/deab155.

Article  CAS  PubMed  Google Scholar 

Ishihara O, Arce J-C. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online [Internet]. 2021;42:909–18. https://doi.org/10.1016/j.rbmo.2021.01.023.

Article  CAS  PubMed  Google Scholar 

Fernández Sánchez M, Višnová H, Larsson P, Yding Andersen C, Filicori M, Blockeel C, et al. A randomized, controlled, first-in-patient trial of choriogonadotropin beta added to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol. Hum Reprod [Internet]. 2022;37:1161–74. https://doi.org/10.1093/humrep/deac061.

Article  CAS  PubMed  Google Scholar 

Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, et al. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022;20:147.

Article  PubMed  PubMed Central  Google Scholar 

Arce J-C, Larsson P, García-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online [Internet]. 2020;41:616–22. https://www.sciencedirect.com/science/article/pii/S1472648320303771. Accessed 1 Mar 2024.

Shao F, Jiang Y, Ding S, Larsson P, Pinton P, Jonker DM. Pharmacokinetics and Safety of Follitropin Delta in Gonadotropin Down-Regulated Healthy Chinese Women. Clin Drug Investig. 2023;43:37–44.

Article  CAS