Recombinant Gonadotropinler ve Etki Mekanizmaları
Özet
Referanslar
The influence of the pharmaceutical industry on the development of gonadotrophins and ovarian stimulation protocols in assisted reproductive Technologies. Child T, Basseee R, Howles CM. Frontiers in Endocrinol (2025);doi:10.3389/fendo.2025.1536844
Mazer C, Ravetz E. The effect of combined administration of chorionic gonadotrophin and the pituitary synergist on the human ovary. Am J Obstet Gynaecol. (1941)41:474–588. doi: 10.1016/S0002-9378(41)90825-6
MaddockW,LeachR,TokuyamaI,PaulsenC,RoyW.Effectsofhogpituitaryfollicle- stimulating hormone in women: antihormone formation and inhibition of ovarian function. J Clin Endocrinol Metab. (1956) 16:433–48. doi: 10.1210/jcem-16-4433
ColeHH,HartGH.Thepotencyofbloodserumofmaresinprogressivestagesof pregnancy in effecting the sexual maturity of the immature rat. Am J Physiol. (1930) 93:57–68. doi: 10.1152/ajplegacy.1930.93.1.57
Gemzell CA, Diszfalusy E, Tillinger G. Clinical effect of human pituitary follicle stimulating hormone. J Clin Endocrinol Metab. (1958) 18:1333–48. doi:10.1210/jcem- 18-12-1333
Bettendorf G. Human hypophyseal gonadotropin in hypophysectomized women. Int J Fertil. (1963) 8:799–809.
Gemzell CA. Human pituitary gonadotropins in the treatment of sterility. Fertil Steril. (1966) 17:149–59. doi: 10.1016/s0015-0282(16)35880-0
Lazarus L. Suspension of the Australian human pituitary hormone programme. Med J Aust. (1985) 143:57–9. doi: 10.5694/j.1326-5377.1985.tb122796.x
Lunenfeld B, Rabau E, Rumney G, Winkelsberg G. The responsiveness of the human ovary to gonadotrophin (Hypophsis III). Proc Third World CongressGynecology Obstetrics Vienna. (1961) 1:220.
Giudice E, Crisci C, Eshkol A, Papoian R. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine: characterization of non-gonadotrophin proteins. Hum Reprod. (1994) 9:2291–9.doi: 10.1093/oxfordjournals.humrep.a138440
Wolfenson C, Groisman J, Couto AS, Hedenfalk M, Cortvrindt RG, Smitz JE, et al. Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations. Reprod BioMed Online. (2005) 10:442–54. doi: 10.1016/s1472-6483(10)60819-x
van de Weijer BH, Mulders JW, Bos ES, Verhaert PD, van den Hooven HW. Compositional analyses of a human menopausal gonadotrophin preparation extracted from urine (menotropin). Identification of some of its major impurities. Reprod BioMed Online. (2003) 7:547–57. doi: 10.1016/s1472-6483(10)62071-8
Lispi M, Bassett R, Crisci C, Mancinelli M, Martelli F, Ceccarelli D, et al. Comparative assessment of the consistency and quality of a highly purified FSH extracted from human urine (urofollitropin) and a recombinant human FSH (follitropin alpha). Reprod BioMed Online. (2006) 13:179–93. doi: 10.1016/s1472- 6483(10)60613-x
Bassett R, Lispi M, Ceccarelli D, Grimaldi L, Mancinelli M, Martelli F, et al. Analytical identification of additional impurities in urinary-derived gonadotrophins. Reprod BioMed Online. (2009) 19:300–13. doi: 10.1016/s14726483(10)60163-0
Giudice E, Crisci C, Eshkol A, Papoian R. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine: characterization of non-gonadotrophin proteins. Hum Reprod. (1994) 9:2291–9. doi: 10.1093/oxfordjournals.humrep.a138440
Van Dorsselaer A, Carapito C, Delalande F, Schaeffer-Reiss C, Thierse D, Diemer H, et al. Detection of prion protein in urine-derived injectable fertility products by a targeted proteomic approach. PloS One. (2011) 6(3):e17815. doi: 10.1371/journal.pone.001781
BFS Statement on the withdrawl of Metrodin HP. British Fertility Society (2003). Available online at: https://www.britishfertilitysociety.org.uk/press-release/bfs-statement-on-the-withdrawl-of-metrodin-hp/ (Accessed May 22nd 2024).
Tulppala M, Aho M, Tuuri T, Vilska S, Foudila T, Hakala-Ala-Pietilä T, et al. Comparison of two recombinant follicle-stimulating hormone preparations in in-vitro fertilization: a randomized clinical study. Hum Reprod. (1999) 14:2709–15. doi: 10.1093/humrep/14.11.2709
BrinsdenP,AkagbosuF,GibbonsLM,LancasterS,GourdonD,EngrandP,etal. A comparison of the efficacy and tolerability of two recombinant human follicle- stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer. Fertil Steril. (2000) 73:114–6. doi: 10.1016/s0015 0282(99)00450-1
van de Lagemaat R, Timmers CM, Kelder J, van Koppen C, Mosselman S, Hanssen RG. Induction of ovulation by a potent, orally active, low molecular weight agonist (Org 43553) of the luteinizing hormone receptor. Hum Reprod. (2009) 24:640–8. doi: 10.1093/humrep/den412
Fares FA, Suganuma N, Nishimori K, LaPolt PS, Hsueh AJ, Boime I. Design of a long-acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin beta subunit to the follitropin beta subunit. Proc Natl Acad Sci U.S.A. (1992) 89:4304–8. doi: 10.1073/pnas.89.10.4304
Shoham Z, Howles CM, Zalel Y, Weissman A, Insler V. Induction of follicular growth and production of a normal hormonal milieu in spite of using a constant low dose of luteinizing hormone in women with hypogonadotrophic hypogonadism. Hum Reprod. (1994) 9:431–6. doi: 10.1093/oxfordjournals. humrep.a 138523
Loumaye E, Engrand P, Shoham Z, Hillier SG, Baird DT. Clinical evidence for an LH ‘ceiling’ effect induced by administration of recombinant human LH during the late follicular phase of stimulated cycles in World Health Organization type I and type II anovulation. Hum Reprod. (2003) 18:314–22. doi: 10.1093/humrep/deg066
Hugues JN, Soussis J, Calderon I, Balasch J, Anderson RA, Romeu A, et al. Does the addition of recombinant LH in WHO group II anovulatory women over- responding to FSH treatment reduce the number of developing follicles? A döşe finding study. Hum Reprod. (2005) 20:629–35. doi: 10.1093/humrep/deh682
European Recombinant LH Study Group. Human recombinant luteinizing hormone is as effective as, but safer than, urinary human chorionic gonadotrophin in inducing final follicular maturation and ovulation in in vitro fertilization procedures: results of a multicenter double-blind study. J Clin Endocrinol Metab. (2001) 86:2607–18. doi: 10.1210/jcem.86.6.7599
De Moustier B, Brinsden P, Bungum L, Fisch B, Pinkstone S, Warne D, et al. The effects of combined treatment of recombinant (r)FSH and rLH in ratios 1:1, 2:1 and 3:1 in women aged 38–42 years undergoing IVF–ICSI treatment. In: Abstracts of the 18th Annual Meeting of the ESHRE. vol. O-158. Vienna, Austria: Hum Reprod (2002). p. 55.
Behre HM, Howles CM, Longobardi S, PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod BioMed Online. (2015) 31:339 46. doi: 10.1016/j.rbmo.2015.06.002
Lehert P, Kolibianakis EM, Venetis CA, Schertz J, Saunders H, Arriagada P, et al. Recombinant human follicle-stimulating hormone (rFSH) plus recombinant luteinizing hormone versus rFSH alone for ovarian stimulation during assisted reproductive technology: systematic review and meta-analysis. Reprod Biol Endocrinol. (2014) 12:17. doi: 10.1186/1477-7827-12-17
Esteves SC, Yarali H, Vuong LN, Carvalho JF, Özbek IY, Polat M, et al. Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real- world evidence study of 9073 patients. Hum Reprod. (2021) 36:2157–69. doi: 10.1093/ humrep/deab152
Humaidan P, Chin W, Rogoff D, D’Hooghe T, Longobardi S, Hubbard J, et al. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. (2017) 32:544–55. doi: 10.1093/humrep/ dew360
Lehert P, Chin W, Schertz J, D’Hooghe T, Alviggi C, Humaidan P. Predicting live birth for poor ovarian responders: the PROsPeR concept. Reprod BioMed Online. (2018) 37:43–52. doi: 10.1016/j.rbmo.2018.03.013
Arvis P, Massin N, Lehert P. Effect of recombinant LH supplementation on cumulative live birth rate compared with FSH alone in poor ovarian responders: a large, real-world study. Reprod BioMed Online. (2021) 42:546–54. doi: 10.1016/ j.rbmo.2020.08.035
Conforti A, Esteves SC, Humaidan P, Longobardi S, D’Hooghe T, Orvieto R, et al. Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. (2021) 19:91. doi: 10.1186/s12958-021-00759-4
Bielfeld AP, Schwarze JE, Verpillat P, Lispi M, Fischer R, Hayward B, et al. Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35-40 years. Reprod BioMed Online. (2024) 48:103725. doi: 10.1016/j.rbmo.2023.103725
European Medicines Agency. Biosimilar medicines: overview (2023). Available online at: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar- medicines-overview (Accessed May 22nd 2024).
Barrière P, Hamamah S, Arbo E, Avril C, Salle B, Pouly JL, et al. REOLA study group. A real-world study of ART in France (REOLA) comparing a biosimilar rFSH against the originator according to rFSH starting dose. J Gynecol Obstet Hum Reprod. (2023) 52:102510. doi: 10.1016/j.jogoh.2022.102510
Cruz M, Howles CM. Clinical outcomes of three follitropin alfa preparations for ovarian stimulation using an oral micronized progesterone-primed protocol in an oocyte donation program. Front Endocrinol (Lausanne). (2024) 15:1451668. doi: 10.3389/fendo.2024.1451668
de Mora F, Howles CM. Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get? Drug Discovery Today. (2022) 27:2071–5. doi: 10.1016/j.drudis.2022.04.022
European Medicines Agency. EPAR summary for the public Rekovelle follitropin delta (2016). Available online at: https://www.ema.europa.eu/en/documents/overview/ rekovelle-epar summary-public_en.pdf
Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, 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) 36:2452–62. doi: 10.1093/humrep/deab155
Nelson SM, Shaw M, Alrashid K, Anderson RA. Individualized dosing of follitropin delta affects live birth and safety in in vitro fertilization treatment: an individual participant data meta-analysis of randomized controlled trials. Fertil Steril. (2024) 122:445–54. doi: 10.1016/j.fertnstert.2024.05.143
Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. (2006) 21:3217–27. doi: 10.1093/humrep/del284
Trew GH. Comparing highly purified hMG and rFSH in patients undergoing IVF. Hum Reprod. (2007) 22:1797–8. doi: 10.1093/humrep/dem049
van Wely M, Kwan I, Burt AL, Thomas J, Vail A, van der Veen F, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev. (2011) 2011:CD005354. doi: 10.1002/14651858.CD005354.pub2
Arce JC, Smitz J. Live-birth rates after HP-hMG stimulation in the long GnRH agonist protocol: association with mid-follicular hCG and progesterone concentrations, but not with LH concentrations. Gynecol Endocrinol. (2013) 29:46–50. doi: 10.3109/ 09513590.2012.705379
FernándezSánchezM,VisňováH,LarssonP,YdingAndersenC,FilicoriM, Blockeel C, et al. A randomized, controlled, first-in-patient trial of choriogonadotrophin beta added to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol. Hum Reprod. (2022) 37:1161–74. doi: 10.1093/humrep/deac061
Lambalk CB, Banga FR, Huirne JA, Toftager M, Pinborg A, Homburg R, et al. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta- analysis accounting for patient type. Hum Reprod Update. (2017) 23:560–79. doi: 10.1093/humupd/dmx017
Melo P, Eapen A, Chung Y, Jeve Y, Price MJ, Sunkara SK, et al. Controlled ovarian stimulation (COS) protocols for assisted reproduction: a Cochrane systematic review and network meta-analysis, (O-009). Hum Reprod. (2022) 37:deac104.009. doi: 10.1093/humrep/deac104.009
Referanslar
The influence of the pharmaceutical industry on the development of gonadotrophins and ovarian stimulation protocols in assisted reproductive Technologies. Child T, Basseee R, Howles CM. Frontiers in Endocrinol (2025);doi:10.3389/fendo.2025.1536844
Mazer C, Ravetz E. The effect of combined administration of chorionic gonadotrophin and the pituitary synergist on the human ovary. Am J Obstet Gynaecol. (1941)41:474–588. doi: 10.1016/S0002-9378(41)90825-6
MaddockW,LeachR,TokuyamaI,PaulsenC,RoyW.Effectsofhogpituitaryfollicle- stimulating hormone in women: antihormone formation and inhibition of ovarian function. J Clin Endocrinol Metab. (1956) 16:433–48. doi: 10.1210/jcem-16-4433
ColeHH,HartGH.Thepotencyofbloodserumofmaresinprogressivestagesof pregnancy in effecting the sexual maturity of the immature rat. Am J Physiol. (1930) 93:57–68. doi: 10.1152/ajplegacy.1930.93.1.57
Gemzell CA, Diszfalusy E, Tillinger G. Clinical effect of human pituitary follicle stimulating hormone. J Clin Endocrinol Metab. (1958) 18:1333–48. doi:10.1210/jcem- 18-12-1333
Bettendorf G. Human hypophyseal gonadotropin in hypophysectomized women. Int J Fertil. (1963) 8:799–809.
Gemzell CA. Human pituitary gonadotropins in the treatment of sterility. Fertil Steril. (1966) 17:149–59. doi: 10.1016/s0015-0282(16)35880-0
Lazarus L. Suspension of the Australian human pituitary hormone programme. Med J Aust. (1985) 143:57–9. doi: 10.5694/j.1326-5377.1985.tb122796.x
Lunenfeld B, Rabau E, Rumney G, Winkelsberg G. The responsiveness of the human ovary to gonadotrophin (Hypophsis III). Proc Third World CongressGynecology Obstetrics Vienna. (1961) 1:220.
Giudice E, Crisci C, Eshkol A, Papoian R. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine: characterization of non-gonadotrophin proteins. Hum Reprod. (1994) 9:2291–9.doi: 10.1093/oxfordjournals.humrep.a138440
Wolfenson C, Groisman J, Couto AS, Hedenfalk M, Cortvrindt RG, Smitz JE, et al. Batch-to-batch consistency of human-derived gonadotrophin preparations compared with recombinant preparations. Reprod BioMed Online. (2005) 10:442–54. doi: 10.1016/s1472-6483(10)60819-x
van de Weijer BH, Mulders JW, Bos ES, Verhaert PD, van den Hooven HW. Compositional analyses of a human menopausal gonadotrophin preparation extracted from urine (menotropin). Identification of some of its major impurities. Reprod BioMed Online. (2003) 7:547–57. doi: 10.1016/s1472-6483(10)62071-8
Lispi M, Bassett R, Crisci C, Mancinelli M, Martelli F, Ceccarelli D, et al. Comparative assessment of the consistency and quality of a highly purified FSH extracted from human urine (urofollitropin) and a recombinant human FSH (follitropin alpha). Reprod BioMed Online. (2006) 13:179–93. doi: 10.1016/s1472- 6483(10)60613-x
Bassett R, Lispi M, Ceccarelli D, Grimaldi L, Mancinelli M, Martelli F, et al. Analytical identification of additional impurities in urinary-derived gonadotrophins. Reprod BioMed Online. (2009) 19:300–13. doi: 10.1016/s14726483(10)60163-0
Giudice E, Crisci C, Eshkol A, Papoian R. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine: characterization of non-gonadotrophin proteins. Hum Reprod. (1994) 9:2291–9. doi: 10.1093/oxfordjournals.humrep.a138440
Van Dorsselaer A, Carapito C, Delalande F, Schaeffer-Reiss C, Thierse D, Diemer H, et al. Detection of prion protein in urine-derived injectable fertility products by a targeted proteomic approach. PloS One. (2011) 6(3):e17815. doi: 10.1371/journal.pone.001781
BFS Statement on the withdrawl of Metrodin HP. British Fertility Society (2003). Available online at: https://www.britishfertilitysociety.org.uk/press-release/bfs-statement-on-the-withdrawl-of-metrodin-hp/ (Accessed May 22nd 2024).
Tulppala M, Aho M, Tuuri T, Vilska S, Foudila T, Hakala-Ala-Pietilä T, et al. Comparison of two recombinant follicle-stimulating hormone preparations in in-vitro fertilization: a randomized clinical study. Hum Reprod. (1999) 14:2709–15. doi: 10.1093/humrep/14.11.2709
BrinsdenP,AkagbosuF,GibbonsLM,LancasterS,GourdonD,EngrandP,etal. A comparison of the efficacy and tolerability of two recombinant human follicle- stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer. Fertil Steril. (2000) 73:114–6. doi: 10.1016/s0015 0282(99)00450-1
van de Lagemaat R, Timmers CM, Kelder J, van Koppen C, Mosselman S, Hanssen RG. Induction of ovulation by a potent, orally active, low molecular weight agonist (Org 43553) of the luteinizing hormone receptor. Hum Reprod. (2009) 24:640–8. doi: 10.1093/humrep/den412
Fares FA, Suganuma N, Nishimori K, LaPolt PS, Hsueh AJ, Boime I. Design of a long-acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin beta subunit to the follitropin beta subunit. Proc Natl Acad Sci U.S.A. (1992) 89:4304–8. doi: 10.1073/pnas.89.10.4304
Shoham Z, Howles CM, Zalel Y, Weissman A, Insler V. Induction of follicular growth and production of a normal hormonal milieu in spite of using a constant low dose of luteinizing hormone in women with hypogonadotrophic hypogonadism. Hum Reprod. (1994) 9:431–6. doi: 10.1093/oxfordjournals. humrep.a 138523
Loumaye E, Engrand P, Shoham Z, Hillier SG, Baird DT. Clinical evidence for an LH ‘ceiling’ effect induced by administration of recombinant human LH during the late follicular phase of stimulated cycles in World Health Organization type I and type II anovulation. Hum Reprod. (2003) 18:314–22. doi: 10.1093/humrep/deg066
Hugues JN, Soussis J, Calderon I, Balasch J, Anderson RA, Romeu A, et al. Does the addition of recombinant LH in WHO group II anovulatory women over- responding to FSH treatment reduce the number of developing follicles? A döşe finding study. Hum Reprod. (2005) 20:629–35. doi: 10.1093/humrep/deh682
European Recombinant LH Study Group. Human recombinant luteinizing hormone is as effective as, but safer than, urinary human chorionic gonadotrophin in inducing final follicular maturation and ovulation in in vitro fertilization procedures: results of a multicenter double-blind study. J Clin Endocrinol Metab. (2001) 86:2607–18. doi: 10.1210/jcem.86.6.7599
De Moustier B, Brinsden P, Bungum L, Fisch B, Pinkstone S, Warne D, et al. The effects of combined treatment of recombinant (r)FSH and rLH in ratios 1:1, 2:1 and 3:1 in women aged 38–42 years undergoing IVF–ICSI treatment. In: Abstracts of the 18th Annual Meeting of the ESHRE. vol. O-158. Vienna, Austria: Hum Reprod (2002). p. 55.
Behre HM, Howles CM, Longobardi S, PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod BioMed Online. (2015) 31:339 46. doi: 10.1016/j.rbmo.2015.06.002
Lehert P, Kolibianakis EM, Venetis CA, Schertz J, Saunders H, Arriagada P, et al. Recombinant human follicle-stimulating hormone (rFSH) plus recombinant luteinizing hormone versus rFSH alone for ovarian stimulation during assisted reproductive technology: systematic review and meta-analysis. Reprod Biol Endocrinol. (2014) 12:17. doi: 10.1186/1477-7827-12-17
Esteves SC, Yarali H, Vuong LN, Carvalho JF, Özbek IY, Polat M, et al. Cumulative delivery rate per aspiration IVF/ICSI cycle in POSEIDON patients: a real- world evidence study of 9073 patients. Hum Reprod. (2021) 36:2157–69. doi: 10.1093/ humrep/deab152
Humaidan P, Chin W, Rogoff D, D’Hooghe T, Longobardi S, Hubbard J, et al. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. (2017) 32:544–55. doi: 10.1093/humrep/ dew360
Lehert P, Chin W, Schertz J, D’Hooghe T, Alviggi C, Humaidan P. Predicting live birth for poor ovarian responders: the PROsPeR concept. Reprod BioMed Online. (2018) 37:43–52. doi: 10.1016/j.rbmo.2018.03.013
Arvis P, Massin N, Lehert P. Effect of recombinant LH supplementation on cumulative live birth rate compared with FSH alone in poor ovarian responders: a large, real-world study. Reprod BioMed Online. (2021) 42:546–54. doi: 10.1016/ j.rbmo.2020.08.035
Conforti A, Esteves SC, Humaidan P, Longobardi S, D’Hooghe T, Orvieto R, et al. Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. (2021) 19:91. doi: 10.1186/s12958-021-00759-4
Bielfeld AP, Schwarze JE, Verpillat P, Lispi M, Fischer R, Hayward B, et al. Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35-40 years. Reprod BioMed Online. (2024) 48:103725. doi: 10.1016/j.rbmo.2023.103725
European Medicines Agency. Biosimilar medicines: overview (2023). Available online at: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar- medicines-overview (Accessed May 22nd 2024).
Barrière P, Hamamah S, Arbo E, Avril C, Salle B, Pouly JL, et al. REOLA study group. A real-world study of ART in France (REOLA) comparing a biosimilar rFSH against the originator according to rFSH starting dose. J Gynecol Obstet Hum Reprod. (2023) 52:102510. doi: 10.1016/j.jogoh.2022.102510
Cruz M, Howles CM. Clinical outcomes of three follitropin alfa preparations for ovarian stimulation using an oral micronized progesterone-primed protocol in an oocyte donation program. Front Endocrinol (Lausanne). (2024) 15:1451668. doi: 10.3389/fendo.2024.1451668
de Mora F, Howles CM. Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get? Drug Discovery Today. (2022) 27:2071–5. doi: 10.1016/j.drudis.2022.04.022
European Medicines Agency. EPAR summary for the public Rekovelle follitropin delta (2016). Available online at: https://www.ema.europa.eu/en/documents/overview/ rekovelle-epar summary-public_en.pdf
Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, 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) 36:2452–62. doi: 10.1093/humrep/deab155
Nelson SM, Shaw M, Alrashid K, Anderson RA. Individualized dosing of follitropin delta affects live birth and safety in in vitro fertilization treatment: an individual participant data meta-analysis of randomized controlled trials. Fertil Steril. (2024) 122:445–54. doi: 10.1016/j.fertnstert.2024.05.143
Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. (2006) 21:3217–27. doi: 10.1093/humrep/del284
Trew GH. Comparing highly purified hMG and rFSH in patients undergoing IVF. Hum Reprod. (2007) 22:1797–8. doi: 10.1093/humrep/dem049
van Wely M, Kwan I, Burt AL, Thomas J, Vail A, van der Veen F, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev. (2011) 2011:CD005354. doi: 10.1002/14651858.CD005354.pub2
Arce JC, Smitz J. Live-birth rates after HP-hMG stimulation in the long GnRH agonist protocol: association with mid-follicular hCG and progesterone concentrations, but not with LH concentrations. Gynecol Endocrinol. (2013) 29:46–50. doi: 10.3109/ 09513590.2012.705379
FernándezSánchezM,VisňováH,LarssonP,YdingAndersenC,FilicoriM, Blockeel C, et al. A randomized, controlled, first-in-patient trial of choriogonadotrophin beta added to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol. Hum Reprod. (2022) 37:1161–74. doi: 10.1093/humrep/deac061
Lambalk CB, Banga FR, Huirne JA, Toftager M, Pinborg A, Homburg R, et al. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta- analysis accounting for patient type. Hum Reprod Update. (2017) 23:560–79. doi: 10.1093/humupd/dmx017
Melo P, Eapen A, Chung Y, Jeve Y, Price MJ, Sunkara SK, et al. Controlled ovarian stimulation (COS) protocols for assisted reproduction: a Cochrane systematic review and network meta-analysis, (O-009). Hum Reprod. (2022) 37:deac104.009. doi: 10.1093/humrep/deac104.009
