Репродуктивная медицина активно развивается, разрабатываются и вводятся в практику новые методы, препараты и протоколы лечения бесплодия. Вспомогательные репродуктивные технологии (ВРТ) включают наиболее эффективные методы его лечения. В протоколах ВРТ овариальная стимуляция (ОС) основана на использовании препаратов гонадотропинов. Выбор стартовой дозы гонадотропина – ключевой фактор успешной ОС и эффективности программ ВРТ. В статье описывается история создания гонадотропинов, приводятся современные данные о применении основных из них в программах ВРТ. Излагаются возможности использования биоаналогов фоллитропина альфа в ОС, а также рассматривается эффективность применения его отечественного биоаналога.
Reproductive medicine is actively developing, and new methods, drugs, and protocols are being developed and introduced for the treatment of infertility. Assisted reproductive technologies (ART) are the most effective methods. In ART protocols, ovarian stimulation (OS) is based on gonadotropin use. The choice of the starting dose of gonadotropin is a critical factor in the successful OS and the effectiveness of ART programs. The article describes the development history of gonadotropins and provides current data on their use in ART programs. The use of biosimilars of follitropin alfa in OS is discussed, and the effectiveness of its Russian biosimilar is also addressed.
1. Papageorgiou K, Mastora E, Zikopoulos A, et al. Interplay Between mTOR and Hippo Signaling in the Ovary: Clinical Choice Guidance Between Different Gonadotropin Preparations for Better IVF. Front Endocrinol (Lausanne). 2021;12:702446. DOI:10.3389/fendo.2021.702446
2. Moolhuijsen LME, Visser JA. Anti-Müllerian Hormone and Ovarian Reserve: Update on Assessing Ovarian Function. J Clin Endocrinol Metab. 2020;105(11):3361-73. DOI:10.1210/clinem/dgaa513
3. Lunenfeld B, Bilger W, Longobardi S, et al. Decision points for individualized hormonal stimulation with recombinant gonadotropins for treatment of women with infertility. Gynecol Endocrinol. 2019;35(12):1027-36. DOI:10.1080/09513590.2019.1650345
4. Brown J, Farquhar C. Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome. Cochrane Database Syst Rev. 2016;12(12):CD002249. DOI:10.1002/14651858.CD002249.pub5
5. Gadalla MA, Huang S, Wang R, et al. Effect of clomiphene citrate on endometrial thickness, ovulation, pregnancy and live birth in anovulatory women: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018;51(1):64-76. DOI:10.1002/uog.18933
6. Hembram M, Biswas R, Jain A. A Study of Controlled Ovarian Stimulation with Clomiphene Citrate or Letrozole in Combination with Gonadotropins and IUI in Unexplained Infertility. J Hum Reprod Sci. 2017;10(3):173-7. DOI:10.4103/jhrs.JHRS_120_16
7. Vyrides AA, El Mahdi E, Giannakou K. Ovulation induction techniques in women with polycystic ovary syndrome. Front Med (Lausanne). 2022;9:982230. DOI:10.3389/fmed.2022.982230
8. Zeng L-H, Rana S, Hussain L, et al. Polycystic Ovary Syndrome: A Disorder of Reproductive Age, Its Pathogenesis, and a Discussion on the Emerging Role of Herbal Remedies. Front Pharmacol. 2022;13:874914. DOI:10.3389/fphar.2022.874914
9. Fevold HL. The gonadotropic hormones. Cold Spring Harbor Symp (Quantitative Biology). 1937;5:93.
10. Borth R, Lunenfeld B, Watteville H. Gonadotropic activity of urinary extracts of climacteric females. Experientia. 1954;10(6):266-8 (in French). DOI:10.1007/BF02157401
11. Lunenfeld B. Treatment of anovulation by human gonadotropins. J Int Fed Gynecol Obstet. 1963;1:15.
12. Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet. 1978;2(8085):366. DOI:10.1016/s0140-6736(78)92957-4
13. Howles CM. Genetic engineering of human FSH (Gonal-F). Hum Reprod Update. 1996;2(2):172-91. DOI:10.1093/humupd/2.2.172
14. Setti PEL, Alviggi C, Colombo GL, et al. Human recombinant follicle stimulating hormone (rFSH) compared to urinary human menopausal gonadotropin (HMG) for ovarian stimulation in assisted reproduction: a literature review and cost evaluation. J Endocrinol Invest. 2015;38(5):497-503. DOI:10.1007/s40618-014-0204-4
15. Коган И.Ю., Гзгзян А.М., Лесик Е.А. Протоколы стимуляции яичников в циклах ВРТ: руководство для врачей. М.: ГЭОТАР-Медиа, 2017 [Kogan IIu, Gzgzian AM, Lesik EA. Protokoly stimuliatsii iaichnikov v tsiklakh VRT: rukovodstvo dlia vrachei. Moscow: GEOTAR-Media, 2017 (in Russian)].
16. Драпкина Ю.С., Макарова Н.П., Смольникова В.Ю. Анализ клинической эффективности человеческих менопаузальных гонадотропинов в программе вспомогательных репродуктивных технологий. Медицинский Совет. 2021;(13):34-41 [Drapkina YuA, Makarova NP, Smolnikova VYu. Analysis of the clinical efficiency of human menopausal gonadotropins in the assisted reproductive technology program. Meditsinskiy sovet = Medical Council. 2021;(13):34-41 (in Russian)]. DOI:10.21518/2079-701X-2021-13-34-41
17. Di Segni N, Busnelli A, Secchi M, et al. Luteinizing hormone supplementation in women with hypogonadotropic hypogonadism seeking fertility care: Insights from a narrative review. Front Endocrinol (Lausanne). 2022;13:907249. DOI:10.3389/fendo.2022.907249
18. Farquhar C, Marjoribanks J. Assisted reproductive technology: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018;8(8):CD010537. DOI:10.1002/14651858.CD010537.pub5
19. Casarini L, Riccetti L, Paradiso E, et al. Two human menopausal gonadotrophin (hMG) preparations display different early signaling in vitro. Mol Hum Reprod. 2020;26(12):894-905. DOI:10.1093/molehr/gaaa070
20. Bühler KF, Fischer R, Verpillat P, et al. Comparative effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG HP) in assisted reproductive technology (ART) treatments: a non-interventional study in Germany. Reprod Biol Endocrinol. 2021;19(1):90. DOI:10.1186/s12958-021-00768-3
21. Рудакова Е.Б., Замаховская Л.Ю., Стрижова Т.В., и др. Исходы экстракорпорального оплодотворения как мультифакторная проблема клинической репродуктологии. Медицинский Совет. 2015;(9):84-91 [Rudakova EB, Zamakhovskaya LY, Strizhova TV, et al. Outcomes of in vitro fertilization as a multifactorial clinical problem or reproductive medicine. Meditsinskiy sovet = Medical Council. 2015;(9):84-91 (in Russian)]. DOI:10.21518/2079-701X-2015-9-84-91
22. Orvieto R, Venetis CA, Fatemi HM, et al. Optimising Follicular Development, Pituitary Suppression, Triggering and Luteal Phase Support During Assisted Reproductive Technology: A Delphi Consensus. Front Endocrinol (Lausanne). 2021;12:675670. DOI:10.3389/fendo.2021.675670
23. Gerli S, Bini V, Favilli A, Di Renzo GC. Clinical efficacy and cost-effectiveness of HP-human FSH (Fostimon®) versus rFSH (Gonal-F®) in IVF-ICSI cycles: a meta-analysis. Gynecol Endocrinol. 2013;29(6):520-9. DOI:10.3109/09513590.2012.758703
24. Haas J, Miller TE, Nahum R, et al. The role of ICSI vs. conventional IVF for patients with advanced maternal age – a randomized controlled trial. J Assist Reprod Genet.
2021;38(1):95-100. DOI:10.1007/s10815-020-01990-5
25. Sánchez MF, Višnová H, Larsson P, 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. 2022;37(6):1161-74. DOI:10.1093/humrep/deac061
26. Venetis CA, Kolibianakis EM, Bosdou JK, Tarlatzis BC. Progesterone elevation and probability of pregnancy after IVF: a systematic review and meta-analysis of over 60 000 cycles. Hum Reprod Update. 2013;19(5):433-57. DOI:10.1093/humupd/dmt014
27. Tal J, Ziskind G, Ohel G. Hp-HMG compared with recombinant FSH reduces the rate of OHSS in high responders in IVF/ICSI by affecting follicular development. Hum Reprod. 2010;25(Suppl. 1):Abstract:527:319.
28. Chen Х, Wei S, Yue L, et al. Serum LH Levels on hCG Trigger Day Affect IVF Outcomes Intensified by Poor Ovarian Reserve and Advanced Age. DOI:10.21203/rs.3.rs-3259838/v1
29. Назаренко Т.А. Клинико-экономическое обоснование применения пролонгированного гонадотропина в программах экстракорпорального оплодотворения и новые возможности корифоллитропина альфа. Гинекология. 2017;19(3):4-11 [Nazarenko TA. Clinical-economic rational of using of prolonged gonadotropin in IVF programs in according to the new opportunities of corifollitropin alfa. Gynecology. 2017;19(3):4-11 (in Russian)]. DOI:10.26442/2079-5696_19.3.4-11
30. Габараева В.В., Калугина А.С. Сравнительная эффективность препарата корифоллитропин-альфа в программе донорства ооцитов. Проблемы репродукции. 2015;21(5):58-62 [Gabaraeva VV, Kalugina AS. Comparative efficacy of the drug corifollitropin-alpha in oocyte donation program. Russian Journal of Human Reproduction.
2015;21(5):58-62 (in Russian)]. DOI:10.17116/repro201521558-62
31. Tarlatzis BC, Griesinger G, Leader A, et al. Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH. Reprod Biomed Online. 2012;24(4):410-9. DOI:10.1016/j.rbmo.2012.01.005
32. Назаренко Т.А., Боярский К.Ю., Горская О.С., и др. Клинические аспекты применения корифоллитропина альфа в программах ВРТ. Проблемы репродукции. 2014;(6):23-7 [Nazarenko TA, Khan TV, Gorskaia OS, et al. Clinical aspects of controlled ovarian stimulation with corifollitropin alfa in ART. Russian Journal of Human Reproduction. 2014;(6):23-7 (in Russian)]. DOI:10.17116/re- pro201420623-27
33. Souza PMG, de Carvalho BR, Nakagawa HM, et al. Corifollitropin alfa compared to daily rFSH or HP-HMG in GnRH antagonist controlled ovarian stimulation protocol for patients undergoing assisted reproduction. JBRA Assist Reprod. 2017;21(2):67-9. DOI:10.5935/1518-0557.20170017
34. Liu Y, Yang M, Garg V, et al. Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review. Adv Ther. 2019;36(8):1851-77. DOI:10.1007/s12325-019-00998-3
35. Chua SJ, Mol BW, Longobardi S, et al. Biosimilar recombinant follitropin alfa preparations versus the reference product (Gonal-F®) in couples undergoing assisted reproductive technology treatment: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2021;19(1):51. DOI:10.1186/s12958-021-00727-y
36. Hu L, Zhang S, Quan S, et al. Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer. Aging (Albany NY). 2020;12(6):4918-30. DOI:10.18632/aging.102919
37. Камилова Д.П., Овчинникова М.М., Абляева Э.Ш., и др. Эффективность применения биоаналогового фоллитропина альфа в реальной клинической практике: результаты наблюдательного исследования «ФОЛЛИТРОПИН». Акушерство, Гинекология и Репродукция. 2021;15(1):5-21 [Kamilova DP, Ovchinnikova MM, Ablyaeva ESh, et al. An observational study “FOLLITROPIN” comparing the efficacy of follitropin alpha biosimilar: the real-world data. Obstetrics, Gynecology and Reproduction. 2021;15(1):5-21 (in Russian)]. DOI:10.17749/2313-7347/ob.gyn.rep.2021.212
38. Курцер М.А., Касьянова Г.В., Овчинникова М.М., Хетагурова Д.Т. Ретроспективное сравнительное исследование исходов вспомогательных репродуктивных технологий у женщин в программах экстракорпорального оплодотворения с применением рекомбинантных гонадотропинов. Акушерство, Гинекология и Репродукция.
2022;16(3):277-86 [Kurtser MA, Kasyanova GV, Ovchinnikova MM, Khetagurova DT. Retrospective comparative study on artificial reproductive technology outcomes in women undergoing in vitro fertilization with recombinant gonadotropins. Obstetrics, Gynecology and Reproduction. 2022;16(3):277-86 (in Russian)].
DOI:10.17749/2313-7347/ob.gyn.rep.2022.304
39. Budani MC, Fensore S, Di Marzio M, Tiboni GM. Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysis. Gynecol Endocrinol. 2021;37(5):406-14. DOI:10.1080/09513590.2020.1792437
40. De Mora F, Howles CM. Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get? Drug Discov Today. 2022;27(8):2071-5. DOI:10.1016/j.drudis.2022.04.022
41. Экспертный совет по возможностям импортозамещения препаратов фоллитропина альфа в циклах ЭКО. Акушерство, Гинекология и Репродукция. 2021;15(4):470-92 [Advisory Board on potential import substitution of follitropin alfa preparations in IVF cycles. Obstetrics, Gynecology and Reproduction. 2021;15(4):470-92 (in Russian)]. DOI:10.17749/2313-7347/ob.gyn.rep.2021.246
42. Виноградова Л.В., Мишиева Н.Г., Абубакиров А.Н., и др. Гормональные особенности циклов ВРТ, стимулированных человеческим менопаузальным гонадотропином и рекомбинантным ФСГ в протоколах с антагонистом гонадотропин-рилизинг-гормона. Акушерство и гинекология. 2014,11:88-95 [Vinogradova LV, Mishieva NG, Abubakirov AN, et al. Hormonal peculiarities of IVF cycles stimulated by human menopausal gonadotropin and recombinant FSH in protocols with antagonist of gonadotropin-releasing-hormone. Obstetrics and Gynecology. 2014;11:88-95 (in Russian)].
43. Калугина А.С., Ткачук А.Г. Эффективность применения рекомбинантного лютеинизирующего гормона: логичный выбор для сложного пациента в программах вспомогательных репродуктивных технологий. Проблемы репродукции. 2019;25(3):63-71 [Kalugina AS, Tkachuk AG. Effectiveness of recombinant luteinizing hormone application: a logical choice for a complex patient in ART programs. Russian Journal of Human Reproduction. 2019;25(3):63-71 (in Russian)]. DOI:10.17116/repro20192503163
44. Al Wattar BH, Talaulikar V. In praise of ovulation induction for the management of anovulatory subfertility. Reprod Biomed Online. 2023;47(2):103219. DOI:10.1016/j.rbmo.2023.04.010
45. Hill MJ, Levy G, Levens ED. Does exogenous LH in ovarian stimulation improve assisted reproduction success? An appraisal of the literature. Reprod Biomed Online.
2012;24(3):261-71. DOI:10.1016/j.rbmo.2011.12.005
46. Humaidan P, La Marca A, Alviggi C, et al. Future Perspectives of POSEIDON Stratification for Clinical Practice and Research. Front Endocrinol (Lausanne). 2019;10:439. DOI:10.3389/fendo.2019.00439
47. Lehert P, Kolibianakis EM, Venetis CA, et al. Recombinant human follicle-stimulating hormone (r-hFSH) plus recombinant luteinizing hormone versus r-hFSH 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
48. Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged ≥35 years: a randomized controlled trial. Hum Reprod. 2015;30(5):1188-95. DOI:10.1093/humrep/dev038
49. Mochtar MH, Danhof N, Ayeleke RO, et al. Recombinant luteinizing hormone (rLH) and recombinant follicle stimulating hormone (rFSH) for ovarian stimulation in IVF/ICSI cycles. Cochrane Database Syst Rev. 2017;(5):CD005070. DOI:10.1002/14651858. cd005070.pub3
50. König TE, van der Houwen LEE, Overbeek A, et al. Recombinant LH supplementation to a standard GnRH antagonist protocol in women of 35 years or older undergoing IVF/ICSI: a randomized controlled multicentre study. Hum Reprod. 2013;28(10):2804-12. DOI:10.1093/humrep/det266
51. Калугина А.А., Боярский К.Ю., Маколкин А.А., и др. Обзор результатов клинических исследований фоллитропина дельта в протоколах овариальной стимуляции. Первый опыт применения в России. Акушерство и гинекология. 2021;11:246-64 [Kalugina AA, Boyarsky KYu, Makolkin AA. Review of the results of clinical studies of follitropin delta in ovarian stimulation protocols. The first experience of its use in Russia. Obstetrics and Gynegology. 2021;11:246-64 (in Russian)]. DOI:10.18565/aig.2021.11.246-264
52. Fernández Sánchez M, Višnová H, Larsson P, 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. 2022;37(6):1161-74. DOI:10.1093/humrep/deac061
53. Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Front Endocrinol (Lausanne). 2022;13:992677. DOI:10.3389/fendo.2022.992677
________________________________________________
1. Papageorgiou K, Mastora E, Zikopoulos A, et al. Interplay Between mTOR and Hippo Signaling in the Ovary: Clinical Choice Guidance Between Different Gonadotropin Preparations for Better IVF. Front Endocrinol (Lausanne). 2021;12:702446. DOI:10.3389/fendo.2021.702446
2. Moolhuijsen LME, Visser JA. Anti-Müllerian Hormone and Ovarian Reserve: Update on Assessing Ovarian Function. J Clin Endocrinol Metab. 2020;105(11):3361-73. DOI:10.1210/clinem/dgaa513
3. Lunenfeld B, Bilger W, Longobardi S, et al. Decision points for individualized hormonal stimulation with recombinant gonadotropins for treatment of women with infertility. Gynecol Endocrinol. 2019;35(12):1027-36. DOI:10.1080/09513590.2019.1650345
4. Brown J, Farquhar C. Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome. Cochrane Database Syst Rev. 2016;12(12):CD002249. DOI:10.1002/14651858.CD002249.pub5
5. Gadalla MA, Huang S, Wang R, et al. Effect of clomiphene citrate on endometrial thickness, ovulation, pregnancy and live birth in anovulatory women: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018;51(1):64-76. DOI:10.1002/uog.18933
6. Hembram M, Biswas R, Jain A. A Study of Controlled Ovarian Stimulation with Clomiphene Citrate or Letrozole in Combination with Gonadotropins and IUI in Unexplained Infertility. J Hum Reprod Sci. 2017;10(3):173-7. DOI:10.4103/jhrs.JHRS_120_16
7. Vyrides AA, El Mahdi E, Giannakou K. Ovulation induction techniques in women with polycystic ovary syndrome. Front Med (Lausanne). 2022;9:982230. DOI:10.3389/fmed.2022.982230
8. Zeng L-H, Rana S, Hussain L, et al. Polycystic Ovary Syndrome: A Disorder of Reproductive Age, Its Pathogenesis, and a Discussion on the Emerging Role of Herbal Remedies. Front Pharmacol. 2022;13:874914. DOI:10.3389/fphar.2022.874914
9. Fevold HL. The gonadotropic hormones. Cold Spring Harbor Symp (Quantitative Biology). 1937;5:93.
10. Borth R, Lunenfeld B, Watteville H. Gonadotropic activity of urinary extracts of climacteric females. Experientia. 1954;10(6):266-8 (in French). DOI:10.1007/BF02157401
11. Lunenfeld B. Treatment of anovulation by human gonadotropins. J Int Fed Gynecol Obstet. 1963;1:15.
12. Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet. 1978;2(8085):366. DOI:10.1016/s0140-6736(78)92957-4
13. Howles CM. Genetic engineering of human FSH (Gonal-F). Hum Reprod Update. 1996;2(2):172-91. DOI:10.1093/humupd/2.2.172
14. Setti PEL, Alviggi C, Colombo GL, et al. Human recombinant follicle stimulating hormone (rFSH) compared to urinary human menopausal gonadotropin (HMG) for ovarian stimulation in assisted reproduction: a literature review and cost evaluation. J Endocrinol Invest. 2015;38(5):497-503. DOI:10.1007/s40618-014-0204-4
15. Kogan IIu, Gzgzian AM, Lesik EA. Protokoly stimuliatsii iaichnikov v tsiklakh VRT: rukovodstvo dlia vrachei. Moscow: GEOTAR-Media, 2017 (in Russian).
16. Drapkina YuA, Makarova NP, Smolnikova VYu. Analysis of the clinical efficiency of human menopausal gonadotropins in the assisted reproductive technology program. Meditsinskiy sovet = Medical Council. 2021;(13):34-41 (in Russian). DOI:10.21518/2079-701X-2021-13-34-41
17. Di Segni N, Busnelli A, Secchi M, et al. Luteinizing hormone supplementation in women with hypogonadotropic hypogonadism seeking fertility care: Insights from a narrative review. Front Endocrinol (Lausanne). 2022;13:907249. DOI:10.3389/fendo.2022.907249
18. Farquhar C, Marjoribanks J. Assisted reproductive technology: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018;8(8):CD010537. DOI:10.1002/14651858.CD010537.pub5
19. Casarini L, Riccetti L, Paradiso E, et al. Two human menopausal gonadotrophin (hMG) preparations display different early signaling in vitro. Mol Hum Reprod. 2020;26(12):894-905. DOI:10.1093/molehr/gaaa070
20. Bühler KF, Fischer R, Verpillat P, et al. Comparative effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG HP) in assisted reproductive technology (ART) treatments: a non-interventional study in Germany. Reprod Biol Endocrinol. 2021;19(1):90. DOI:10.1186/s12958-021-00768-3
21. Rudakova EB, Zamakhovskaya LY, Strizhova TV, et al. Outcomes of in vitro fertilization as a multifactorial clinical problem or reproductive medicine. Meditsinskiy sovet = Medical Council. 2015;(9):84-91 (in Russian). DOI:10.21518/2079-701X-2015-9-84-91
22. Orvieto R, Venetis CA, Fatemi HM, et al. Optimising Follicular Development, Pituitary Suppression, Triggering and Luteal Phase Support During Assisted Reproductive Technology: A Delphi Consensus. Front Endocrinol (Lausanne). 2021;12:675670. DOI:10.3389/fendo.2021.675670
23. Gerli S, Bini V, Favilli A, Di Renzo GC. Clinical efficacy and cost-effectiveness of HP-human FSH (Fostimon®) versus rFSH (Gonal-F®) in IVF-ICSI cycles: a meta-analysis. Gynecol Endocrinol. 2013;29(6):520-9. DOI:10.3109/09513590.2012.758703
24. Haas J, Miller TE, Nahum R, et al. The role of ICSI vs. conventional IVF for patients with advanced maternal age – a randomized controlled trial. J Assist Reprod Genet.
2021;38(1):95-100. DOI:10.1007/s10815-020-01990-5
25. Sánchez MF, Višnová H, Larsson P, 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. 2022;37(6):1161-74. DOI:10.1093/humrep/deac061
26. Venetis CA, Kolibianakis EM, Bosdou JK, Tarlatzis BC. Progesterone elevation and probability of pregnancy after IVF: a systematic review and meta-analysis of over 60 000 cycles. Hum Reprod Update. 2013;19(5):433-57. DOI:10.1093/humupd/dmt014
27. Tal J, Ziskind G, Ohel G. Hp-HMG compared with recombinant FSH reduces the rate of OHSS in high responders in IVF/ICSI by affecting follicular development. Hum Reprod. 2010;25(Suppl. 1):Abstract:527:319.
28. Chen Х, Wei S, Yue L, et al. Serum LH Levels on hCG Trigger Day Affect IVF Outcomes Intensified by Poor Ovarian Reserve and Advanced Age. DOI:10.21203/rs.3.rs-3259838/v1
29. Nazarenko TA. Clinical-economic rational of using of prolonged gonadotropin in IVF programs in according to the new opportunities of corifollitropin alfa. Gynecology.
2017;19(3):4-11 (in Russian). DOI:10.26442/2079-5696_19.3.4-11
30. Gabaraeva VV, Kalugina AS. Comparative efficacy of the drug corifollitropin-alpha in oocyte donation program. Russian Journal of Human Reproduction. 2015;21(5):58-62 (in Russian). DOI:10.17116/repro201521558-62
31. Tarlatzis BC, Griesinger G, Leader A, et al. Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH. Reprod Biomed Online. 2012;24(4):410-9. DOI:10.1016/j.rbmo.2012.01.005
32. Nazarenko TA, Khan TV, Gorskaia OS, et al. Clinical aspects of controlled ovarian stimulation with corifollitropin alfa in ART. Russian Journal of Human Reproduction. 2014;(6):23-7 (in Russian). DOI:10.17116/re- pro201420623-27
33. Souza PMG, de Carvalho BR, Nakagawa HM, et al. Corifollitropin alfa compared to daily rFSH or HP-HMG in GnRH antagonist controlled ovarian stimulation protocol for patients undergoing assisted reproduction. JBRA Assist Reprod. 2017;21(2):67-9. DOI:10.5935/1518-0557.20170017
34. Liu Y, Yang M, Garg V, et al. Economic Impact of Non-Medical Switching from Originator Biologics to Biosimilars: A Systematic Literature Review. Adv Ther. 2019;36(8):1851-77. DOI:10.1007/s12325-019-00998-3
35. Chua SJ, Mol BW, Longobardi S, et al. Biosimilar recombinant follitropin alfa preparations versus the reference product (Gonal-F®) in couples undergoing assisted reproductive technology treatment: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2021;19(1):51. DOI:10.1186/s12958-021-00727-y
36. Hu L, Zhang S, Quan S, et al. Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer. Aging (Albany NY). 2020;12(6):4918-30. DOI:10.18632/aging.102919
37. Kamilova DP, Ovchinnikova MM, Ablyaeva ESh, et al. An observational study “FOLLITROPIN” comparing the efficacy of follitropin alpha biosimilar: the real-world data. Obstetrics, Gynecology and Reproduction. 2021;15(1):5-21 (in Russian). DOI:10.17749/2313-7347/ob.gyn.rep.2021.212
38. Kurtser MA, Kasyanova GV, Ovchinnikova MM, Khetagurova DT. Retrospective comparative study on artificial reproductive technology outcomes in women undergoing in vitro fertilization with recombinant gonadotropins. Obstetrics, Gynecology and Reproduction. 2022;16(3):277-86 (in Russian). DOI:10.17749/2313-7347/ob.gyn.rep.2022.304
39. Budani MC, Fensore S, Di Marzio M, Tiboni GM. Efficacy and safety of follitropin alpha biosimilars compared to their reference product: a Meta-analysis. Gynecol Endocrinol. 2021;37(5):406-14. DOI:10.1080/09513590.2020.1792437
40. De Mora F, Howles CM. Overlapping biosimilar and originator follitropin alfa preparations: How much closer can they get? Drug Discov Today. 2022;27(8):2071-5. DOI:10.1016/j.drudis.2022.04.022
41. Advisory Board on potential import substitution of follitropin alfa preparations in IVF cycles. Obstetrics, Gynecology and Reproduction. 2021;15(4):470-92 (in Russian). DOI:10.17749/2313-7347/ob.gyn.rep.2021.246
42. Vinogradova LV, Mishieva NG, Abubakirov AN, et al. Hormonal peculiarities of IVF cycles stimulated by human menopausal gonadotropin and recombinant FSH in protocols with antagonist of gonadotropin-releasing-hormone. Obstetrics and Gynecology. 2014;11:88-95 (in Russian).
43. Kalugina AS, Tkachuk AG. Effectiveness of recombinant luteinizing hormone application: a logical choice for a complex patient in ART programs. Russian Journal of Human Reproduction. 2019;25(3):63-71 (in Russian). DOI:10.17116/repro20192503163
44. Al Wattar BH, Talaulikar V. In praise of ovulation induction for the management of anovulatory subfertility. Reprod Biomed Online. 2023;47(2):103219. DOI:10.1016/j.rbmo.2023.04.010
45. Hill MJ, Levy G, Levens ED. Does exogenous LH in ovarian stimulation improve assisted reproduction success? An appraisal of the literature. Reprod Biomed Online.
2012;24(3):261-71. DOI:10.1016/j.rbmo.2011.12.005
46. Humaidan P, La Marca A, Alviggi C, et al. Future Perspectives of POSEIDON Stratification for Clinical Practice and Research. Front Endocrinol (Lausanne). 2019;10:439. DOI:10.3389/fendo.2019.00439
47. Lehert P, Kolibianakis EM, Venetis CA, et al. Recombinant human follicle-stimulating hormone (r-hFSH) plus recombinant luteinizing hormone versus r-hFSH 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
48. Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged ≥35 years: a randomized controlled trial. Hum Reprod. 2015;30(5):1188-95. DOI:10.1093/humrep/dev038
49. Mochtar MH, Danhof N, Ayeleke RO, et al. Recombinant luteinizing hormone (rLH) and recombinant follicle stimulating hormone (rFSH) for ovarian stimulation in IVF/ICSI cycles. Cochrane Database Syst Rev. 2017;(5):CD005070. DOI:10.1002/14651858. cd005070.pub3
50. König TE, van der Houwen LEE, Overbeek A, et al. Recombinant LH supplementation to a standard GnRH antagonist protocol in women of 35 years or older undergoing IVF/ICSI: a randomized controlled multicentre study. Hum Reprod. 2013;28(10):2804-12. DOI:10.1093/humrep/det266
51. Kalugina AA, Boyarsky KYu, Makolkin AA. Review of the results of clinical studies of follitropin delta in ovarian stimulation protocols. The first experience of its use in Russia. Obstetrics and Gynegology. 2021;11:246-64 (in Russian). DOI:10.18565/aig.2021.11.246-264
52. Fernández Sánchez M, Višnová H, Larsson P, 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. 2022;37(6):1161-74. DOI:10.1093/humrep/deac061
53. Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Front Endocrinol (Lausanne). 2022;13:992677. DOI:10.3389/fendo.2022.992677
1ФГБУ «Государственный научный центр Российской Федерации – Федеральный медицинский биофизический центр им. А.И. Бурназяна» ФМБА России, Москва, Россия; 2ГБУЗ МО «Московский областной перинатальный центр», Балашиха, Россия
*s.ostrina@yandex.ru
________________________________________________
Sabina Ya. Ostrina*1,2, Ol'ga F. Serova1,2, Elena B. Rudakova1,2, Elena A. Fedorova2
1State Research Center – Burnasyan Federal Medical Biophysical Center, Moscow, Russia; 2Moscow Regional Perinatal Center, Balashikha, Russia
*s.ostrina@yandex.ru