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The Journal "Obstetrics and Gynecology"Journal HistoryAims and ScopePolicies on Conflict of Interest, Human and Animal Rights, and Informed ConsentEditorial ProcessData sharing statementAdvertising PolicyThe Process for Handling Cases Requiring Corrections, Retractions, and Editorial Expressions of ConcernEditorial BoardEditorial CounsilInformation for ProfessionalsNewsContacts
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Obstetrics and Gynegology2024№8
The safety of hormone therapy...

The safety of hormone therapy during pregnancy. Joint statement by experts in reproductive medicine, obstetrics and gynecology, endocrinology, clinical pharmacology, neonatology and pediatrics

DOI
https://dx.doi.org/10.18565/aig.2024.201

Sukhikh G.T., Serov V.N., Artymuk N.V., Andreeva M.D., Bazina M.I., Baranov I.I., Bashmakova N.V., Bezhenar V.F., Belotserkovtseva L.D., Geppe N.A., Dolgushina N.V., Zaretskaya N.V., Zakharova I.N., Zubkov V.V., Enkova E.V., Yesayan R.M., Katkova N.Yu., Kvashnina E.V., Kogan I.Yu., Korsak V.S., Krasnopolskaya K.V., Kukarskaya I.I., Molchanova I.V., Nazarenko T.A., Pestova T.I., Podzolkova N.M., Saveljeva I.V., Sazonova A.I., Semenov Yu.A., Tapilskaya N.I., Tetruashvili N.K., Tiselko A.V., Fadeev V.V., Shamugia N.L., Shakhova M.A., Shikh E.V., Yarmolinskaya M.I.

For citation: Sukhikh G.T., Serov V.N., Artymuk N.V., Andreeva M.D., Bazina M.I., Baranov I.I., Bashmakova N.V., Bezhenar V.F., Belotserkovtseva L.D., Geppe N.A., Dolgushina N.V., Zaretskaya N.V., Zakharova I.N., Zubkov V.V., Enkova E.V., Yesayan R.M., Katkova N.Yu., Kvashnina E.V., Kogan I.Yu., Korsak V.S., Krasnopolskaya K.V., Kukarskaya I.I., Molchanova I.V., Nazarenko T.A., Pestova T.I.,  Podzolkova N.M., Saveljeva I.V., Sazonova A.I., Semenov Yu.A., Tapilskaya N.I., Tetruashvili N.K., Tiselko A.V., Fadeev V.V., Shamugia N.L., Shakhova M.A., Shikh E.V., Yarmolinskaya M.I. The safety of hormone therapy during pregnancy. Joint statement by experts in reproductive medicine, obstetrics and gynecology, endocrinology, clinical pharmacology, neonatology and pediatrics.

Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2024; (8): 196-206 (in Russian)

https://dx.doi.org/10.18565/aig.2024.201

Full text (in Russian)

References

  1. Всемирная организация здравоохранения. Исполнительное резюме. Женщины и здоровье. Сегодняшние проблемы. Повестка дня на завтра. ВОЗ; 2009. [WHO. Launch of the report on Women and health: today’s evidence, tomorrow’s agenda. WHO; 2009].
  2. Выкидыш. Клинические рекомендации РОАГ. 2021. [Miscarriage. Clinical guidelines of RSOG. 2021. (in Russian)].
  3. Выкидыш. Клинические рекомендации РОАГ. 2024. [Miscarriage. Clinical guidelines of RSOG. 2024. (in Russian)].
  4. Женское бесплодие. Клинические рекомендации РОАГ. 2021. [Female infertility. Clinical guidelines of RSOG. 2021. (in Russian)].
  5. Женское бесплодие. Клинические рекомендации РОАГ. 2024. [Female infertility. Clinical guidelines of RSOG. 2024. (in Russian)].
  6. Истмико-цервикальная недостаточность. Клинические рекомендации РОАГ. 2021. [Isthmico-cervical insufficiency. Clinical guidelines of RSOG. 2021. (in Russian)].
  7. Привычный выкидыш. Клинические рекомендации РОАГ. 2022. [Habitual miscarriage. Clinical guidelines of RSOG. 2022. (in Russian)].
  8. Нормальная беременноcть. Клинические рекомендации РОАГ. 2023. [Normal pregnancy. Clinical guidelines of RSOG. 2023. (in Russian)].
  9. Многоплодная беременность. Клинические рекомендации РОАГ. 2021. [Multiple pregnancy. Clinical guidelines of RSOG. 2021. (in Russian)].
  10. Венозные осложнения во время беременности и послеродовом периоде. Акушерская тромбоэмболия. Клинические рекомендации РОАГ. 2022. [Venous complications during pregnancy and postpartum. Obstetric thromboembolism. Clinical guidelines of RSOG. 2022. (in Russian)].
  11. Преэклампсия. Эклампсия. Отеки, протеинурия и гипертензивные расстройства во время беременности, в родах и послеродовом периоде. Клинические рекомендации РОАГ. 2021. [Eclampsia. Edema, proteinuria, and hypertensive disorders during pregnancy, delivery, and postpartum. Clinical guidelines of RSOG. 2021. (in Russian)].
  12. Недостаточный рост плода, требующий предоставления медицинской помощи матери (задержка роста плода). Клинические рекомендации РОАГ. 2022. [Insufficient growth of the fetus, requiring the provision of medical care to the mother (fetal growth retardation). Clinical guidelines of RSOG. 2022. (in Russian)].
  13. Shehata H., Elfituri A., Doumouchtsis S.K., Zini M.E., Ali A., Jan H. et al. FIGO Good Practice Recommendations on the use of progesterone in the management of recurrent first-trimester miscarriage. Int. J. Gynaecol. Obstet. 2023; 161 Suppl 1: 3-16. https://dx.doi.org/10.1002/ijgo. 14717.
  14. Recurrent Pregnancy Loss. Guideline of European Society of Human Reproduction and Embryology. 2023.
  15. NICE. Ectopic pregnancy and miscarriage: diagnosis and initial management. NICE guideline [NG126]. Published: 17 April 2019 Last updated: 29 August 2023.
  16. Bosch E., Broer S., Griesinger G., Grynberg M., Humaidan P., Kolibianakis E. et al.; ESHRE Guideline Group on Ovarian Stimulation. ESHRE guideline: ovarian stimulation for IVF/ICSI. Hum. Reprod. Open. 2020; 2020(2): hoaa009. https://dx.doi.org/10.1093/hropen/hoaa009.
  17. Федеральный закон от 21.11.2011 N 323-ФЗ (ред. от 02.07.2021) «Об основах охраны здоровья граждан в Российской Федерации» (с изм. и доп., вступ. в силу с 01.10.2021). [Federal Law of 21.11.2011 N 323-FZ (as amended by 02.07.2021) "On the Basics of Protecting the Health of Citizens in the Russian Federation" (amended and supplemented, entry by virtue of 01.10.2021) (in Russian)].
  18. Сахарный диабет 1 типа у взрослых. Клинические рекомендации РАЭ. 2022. [Type 1 diabetes mellitus in adults. Clinical guidelines of RAE. 2022. (in Russian)].
  19. Гестационный сахарный диабет. Проект клинических рекомендаций РАЭ, РОАГ. 2020. [Gestational diabetes mellitus. Draft of Clinical guidelines of RAE, RSOG. 2020. (in Russian)].
  20. Врожденная дисфункция коры надпочечников (адреногенитальный синдром). Клинические рекомендации РАЭ, РОАГ. 2021. [Congenital adrenal cortex dysfunction (adrenogenital syndrome). Clinical guidelines of RAE, RSOG. 2021 (in Russian)].
  21. Гипотиреоз. Клинические рекомендации РАЭ. 2021. [Hypothyroidism. Clinical guidelines of RAE. 2021. (in Russian)].
  22. Koren G., Barer Y., Cem Kaplan Y. Fetal safety of medications used in treating infertility. Expert. Rev. Clin. Pharmacol. 2020; 13(9): 991-1000. https://dx.doi.org/10.1080/17512433.2020.1803738. Retraction in: Expert Rev. Clin. Pharmacol. 2022; 15(3): i. https://dx.doi.org/10.1080/17512433.2022.2044624.
  23. Zaqout M., Aslem E., Abuqamar M., Abughazza O., Panzer J., De Wolf D. The impact of oral intake of dydrogesterone on fetal heart development during early pregnancy. Pediatr. Cardiol. 2015; 36(7): 1483-8. https://dx.doi.org/10.1007/s00246-015-1190-9.
  24. Henry A., Santulli P., Bourdon M., Treluyer J.M., Chouchana L. O-150 Birth defects reporting and the use of oral dydrogesterone in assisted reproductive technology: a global pharmacovigilance study. Hum. Rep. 2023; 38(Suppl_1): dead093.77. https://dx.doi.org/10.1093/humrep/dead093.177.
  25. Li L., Wang K., Wang M., Tao J., Li X., Liu Z. et al. The maternal drug exposure birth cohort (DEBC) in China. Nat. Commun. 2024; 15(1): 5312. https://dx.doi.org/10.1038/s41467-024-49623-0.
  26. van der Vet P.E., Nijveen H. Propagation of errors in citation networks: a study involving the entire citation network of a widely cited paper published in, and later retracted from, the journal Nature. Res. Integr. Peer Rev. 2016; 1: 3. https://dx.doi.org/10.1186/s41073-016-0008-5.
  27. Померанцева Е.А., Докшукина А.А., Дегтярева А.В., Масленников Д.Н., Трофимов Д.Ю., Дегтярев Д.Н. Критерии оценки фенотипа новорожденного для формирования группы повышенного риска генетических заболеваний. Неонатология: новости, мнения, обучение. 2022; 10(4): 47-53. [Pomerantseva E.A., Dokshukina A.A., Degtyareva A.V., Maslennikov D.N., Trofimov D.Yu., Degtyarev D.N. Criteria of phenotype assessment of newborn for the group formation with increased risk of genetic diseases. Neonatology: News, Opinions, Training. 2022; 10(4): 47-53. (in Russian)]. https://dx.doi.org/10.33029/2308-2402-2022-10-4-47-53.
  28. Российская Ассоциация Репродукции Человека. Регистр ВРТ России. Отчет за 2021 год. [Russian Association for Human Reproduction. Register of ART of Russia. 2021 Report. (in Russian)].
  29. Bosch E., De Vos M., Humaidan P. The future of cryopreservation in assisted reproductive technologies. Front Endocrinol (Lausanne). 2020; 11: 67. https://dx.doi.org/10.3389/fendo.2020.00067.
  30. Ernstad E.G., Wennerholm U.-B., Khatibi A., Petzold M., Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am. J. Obstet. Gynecol. 2019; 221(2): 126.e1-126.e18. https://dx.doi.org/10.1016/j.ajog.2019.03.010.
  31. Башмакова Н.В., Локшин В.Н., Исенова С.Ш., Храмцова А.Ю., Данькова И.В., Рябухин И.В. Сравнительный анализ эффективности программ и перинатальных исходов после переноса размороженных эмбрионов в зависимости от препаратов посттрансферной поддержки. Акушерство и гинекология. 2023; 7: 103-8. [Bashmakova N.V., Lokshin V.N., Isenova S.Sh., Khramtsova A.Yu., Dankova I.V., Ryabukhin I.V. Comparative analysis of the effectiveness of programs and perinatal outcomes after frozen-thawed embryo transfer depending on post-transfer support medications. Obstetrics and Gynecology. 2023; (7): 103-8. (in Russian)]. https://dx.doi.org/10.18565/aig.2023.161.
  32. Общая характеристика лекарственного препарата Эстрожель® гель трансдермальный 0.6 мг/г (флаконы) 80 г, ЛП-№(005618)-(РГ-RU) от 29.05.2024. [Product Characteristics of Estrogel® gel transdermal 0.6 mg/g (vials) 80 g, LP-No.(005618)-(RG-RU) dated 29/05/2024. (in Russian)].
  33. Инструкция по медицинскому применению лекарственного препарата Прогинова® от 14.06.2023. [Instructions for the medical use of the drug Proginova® dated 14/06/2023. (in Russian)].
  34. Инструкция по медицинскому применению лекарственного препарата Дивигель® от 05.05.2023. [Instructions for the medical use of the drug Divigel® dated 05/05/2023. (in Russian)].
  35. Российская Ассоциация Репродукции Человека. Применение эстрогенов в программах ВРТ. Научно-практические рекомендации. 2015. 24 с. [Russian Association of Human Reproduction. Use of estrogens in ART programs. Scientific and practical recommendations. 2015. 24 p. (in Russian)].
  36. Krieg S.A., Henne M.B., Westphal L.M. Obstetric outcomes in donor oocyte pregnancies compared with advanced maternal age in in vitro fertilization pregnancies. Fertil. Steril. 2008; 90(1): 65-70. https://dx.doi.org/10.1016/j.fertnstert.2007.06.014.
  37. Stoop D., Baumgarten M., Haentjens P., Polyzos N.P., De Vos M., Verheyen G. et al. Obstetric outcome in donor oocyte pregnancies: a matched-pair analysis. Reprod. Biol. Endocrinol. 2012; 10: 42. https://dx.doi.org/10.1186/1477-7827-10-42.
  38. Башмакова Н.В., Новоселова Е.Н., Назаренко Т.А., Овчинникова М.М., Фетисова Ю.А., Гергерт Е.В., Ганихина М.А., Валиуллина Н.Г., Головина Е.О., Щербань М.Р., Семихин А.С., Ползиков М.А., Блинов Д.В. Реальная клиническая практика лечения бесплодия в России: мнение 425 врачей- репродуктологов. Акушерство, гинекология и репродукция. 2023; 17(6): 680-706. [Bashmakova N.V., Novoselova E.N., Nazarenko T.A., Ovchinnikova M.M., Fetisova Yu.A., Gergert E.V., Ganikhina M.A., Valiullina N.G., Golovina E.O., Shcherban M.R., Semikhin A.S., Polzikov M.A., Blinov D.V. Real clinical practice of infertility treatment in Russia: a collective opinion of 425 reproductologists. Obstetrics, Gynecology and Reproduction. 2023; 17(6): 680-706. (in Russian)]. https://dx.doi.org/10.17749/2313-7347/ob.gyn.rep.2023.468.
  39. Ших Е.В. Сравнительные клинико-фармакологические аспекты применения пероральных и трансдермальных форм эстрогенов. Акушерство и гинекология: новости, мнения, обучение. 2016; 1: 41-6. [Shikh E.V. Comparative clinical pharmacological aspects of oral and transdermal dosage forms of estrogens. Obstetrics and Gynecology: News, Opinions, Training. 2016; 1: 41-6. (in Russian)].
  40. Тетруашвили Н.К., Серов В.Н. Гестагены при беременности высокого риска. Акушерство и гинекология: новости, мнения, обучение. 2022; 10(2): 31-8. [Tetruashvili N.K., Serov V.N. Gestagens in high-risk pregnancy. Obstetrics and Gynecology: News, Opinions, Training. 2022; 10(2): 31-8. (in Russian)]. https://dx.doi.org/10.33029/2303-9698-2022-10-2-31-38.
  41. Сухих Г.Т., Адамян Л.В., Серов В.Н. и др. Резолюция Экспертного совещания по теме: «Применение гестагенов в репродуктивной медицине. Утверждение протокола многоцентровой программы по изучению предикторов наступления беременности при применении вспомогательных репродуктивных технологий в российской популяции в соответствии с актуальными международными и национальными клиническими рекомендациями (исследование «ИРИС»). Акушерство и гинекология. 2019; 12: 218-25. [Sukhikh G.Т., Adamyan L.V., Serov V.N., et al. Resolution of the Advisory Board on the subject: Multicenter Open-Label Observational Program to Research on Predictors of Pregnancy Rate in Assisted Reproductive Technology in the Russian Population According to Actual International and National Guidelines (IRIS study). Obstetrics and Gynecology. 2019; (12): 218-25. (in Russian)]. https://dx.doi.org/10.18565/aig.2019.12.218-225.
  42. Тетруашвили Н.К., Ших Е.В. Эффективность дидрогестерона при угрожающем выкидыше: систематический обзор и метаанализ. Доктор.Ру. 2022; 21(5): 53–61. [Tetruashvili N.K., Shih E.V. Efficacy of dydrogesterone in threatened miscarriage: a systematic review and meta-analysis. Doctor. Ru. 2022; 21(5): 53-61. (in Russian). https://dx.doi.org/10.31550/1727-2378-2022-21-5-53-61.
  43. Общая характеристика лекарственного препарата Дюфастон® таблетки, покрытые пленочной оболочкой, 10 мг, ЛП-№(001546)-(РГ-RU) от 22.03.2023. [Product Characteristics of Dufaston® 10 mg film-coated tablets, LP-No.(001546)-(RG-RU) dated 22/03/2023 (in Russian)].
  44. Общая характеристика лекарственного препарата Утрожестан® капсулы, 200 мг/1 мг, ЛП-№(005733)-(РГ-RU) от 11.06.2024. [Product Characteristics of Utrogestan® 200 mg/1 mg capsules, LP-No.(005733)-(RG-RU) dated 11/06/2024 (in Russian)].
  45. Schindler A.E. Progestational effects of dydrogesterone in vitro, in vivo and on the human endometrium. Maturitas. 2009; 65(Suppl 1): S3-S11. https://dx.doi.org/10.1016/j.maturitas.2009.10.011
  46. Schindler A.E., Campagnoli C., Druckmann R., Huber J., Pasqualini J.R., Schweppe K.W. et al. Classification and pharmacology of progestins. Maturitas. 2008; 61(1-2): 171-80. https://dx.doi.org/10.1016/j.maturitas.2008.11.013.
  47. Rižner T.L., Brožič P., Doucette C., Turek-Etienne T., Müller-Vieira U., Sonneveld E. et al. Selectivity and potency of the retroprogesterone dydrogesterone in vitro. Steroids. 2011; 76(6): 607-15. https://dx.doi.org/10.1016/j.steroids.2011.02.043.
  48. Бицадзе В.О., Акиньшина С.В., Хизроева Дж.Х., Макацария Н.А., Стулева Н.С., Машкова Т.Я. Патогенетические основы применения терапии естественным прогестероном в акушерской практике. Акушерство, гинекология и репродукция. 2014; 8(2): 79-88. [Bitsadze V.O., Akinshina S.V., Khizroeva J.Kh., Makatsariya N.A., Stuleva N.S., Mashkova T.Ya. The pathogenetic basis for using natural progesterone therapy in obstetric practice. Obstetrics, Gynecology and Reproduction. 2014; 8(2): 79-88. (in Russian)].
  49. Coomarasamy A., Williams H., Truchanowicz E., Seed P.T., Small R., Quenby S. et al. PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation. Health Technol. Assess. 2016; 20(41): 1-92. https://dx.doi.org/10.3310/hta20410.
  50. Coomarasamy A., Devall A.J., Cheed V., Harb H., Middleton L.J., Gallos I.D. et al. A randomized trial of progesterone in women with bleeding in early pregnancy. N. Engl. J. Med. 2019; 380(19): 1815-24. https://dx.doi.org/10.1056/NEJMoa1813730.
  51. Griesinger G., Tournaye H., Macklon N., Petraglia F., Arck P., Blockeel C. et al. Dydrogesterone: pharmacological profile and mechanism of action as luteal phase support in assisted reproduction. Reprod. Biomed. Online. 2019; 38(2): 249-59. https://dx.doi.org/10.1016/j.rbmo.2018.11.017.
  52. Капустин Р.В., Аржанова О.Н., Беспалова О.Н. Экзогенный прогестерон как фактор развития гестационного сахарного диабета. Российский вестник акушера-гинеколога. 2019; 19(1): 38-45. [Kapustin R.V., Arzhanova O.N., Bespalova O.N. Exogenous progesterone as a factor for the development of gestational diabetes mellitus. Russian Bulletin of Obstetrician-Gynecologist. 2019; 19(1): 38-45. (in Russian)]. https://dx.doi.org/10.17116/rosakush20191901138.
  53. Areeruk W., Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci. Rep. 2016; 6: 20638. https://dx.doi.org/10.1038/srep20638.
  54. Zheng Z., Armfield B.A., Cohn M.J. Timing of androgen receptor disruption and estrogen exposure underlies a spectrum of congenital penile anomalies. Proc. Natl. Acad. Sci. U. S. A. 2015; 112(52): E7194-203. https://dx.doi.org/10.1073/pnas.1515981112.
  55. Ott J., Egarter C., Aguilera A. Dydrogesterone after 60 years: a glance at the safety profile. Gynecol. Endocrinol. 2022; 38(4): 279-87. https://dx.doi.org/10.1080/09513590.2021.2016692.
  56. Tournaye H., Sukhikh G.T., Kahler E., Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum. Reprod. 2017; 32(10): 2152. https://dx.doi.org/10.1093/humrep/dex266.
  57. Griesinger G., Blockeel C., Sukhikh G.T., Patki A., Dhorepatil B., Yang D.Z. et al. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum. Reprod. 2018; 33(12): 2212-21. https://dx.doi.org/10.1093/humrep/dey306.
  58. Griesinger G., Blockeel C., Kahler E., Pexman-Fieth C., Olofsson J.I., Driessen S. et al. Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis. PLoS One. 2020; 15(11): e0241044. https://doi.org/10.1371/journal.pone.0241044.
  59. Yang W., Chi H., Yang R., Liu P., Li R., Qiao J. et al. Congenital anomalies after first-trimester dydrogesterone therapy during in vitro fertilization. Fertil. Steril. 2023; 120 (Issue 4, Supplement): E72. https://dx.doi.org/10.1016/j.fertnstert.2023.08.222.
  60. https://pubmed.ncbi.nlm.nih.gov/?term=dydrogesterone+ivf
  61. Patki A. Role of dydrogesterone for luteal phase support in assisted reproduction. Reprod. Sci. 2024; 31(1): 17-29. https://dx.doi.org/10.1007/s43032-023-01302-z.
  62. Katalinic A., Noftz M.R., Garcia-Velasco J.A., Shulman L.P., van den Anker J.N., Strauss Iii J.F. No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis. Hum. Reprod. Open. 2024; 2024(1): hoae004. https://dx.doi.org/10.1093/hropen/hoae004.
  63. Quadros R., Puppalwar G., Mane A., Mehta S. Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects. Hum. Reprod. Open. 2024; 2024(2): hoae030. https://dx.doi.org/10.1093/hropen/hoae030.
  64. Katalinic A. Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects. Hum. Reprod. Open. 2024; 2024(2): hoae031. https://dx.doi.org/10.1093/hropen/hoae031.
  65. Жукова Д.Я., Ковальская Г.Н. Оригинальные и дженерические лекарственные средства в терапевтической практике. Сибирский медицинский журнал. 2011; 7: 96-102. [Zhukova D.Y., Kovalskaya G.N. The original and generic drugs in medical therapy. Siberian Medical Journal. 2011;7: 96-102. (in Russian)].
  66. Соколов А., Кукес В., Бунятян Н., Родина Т., Прокофьев А., Архипов В., Красных Л., Сокова Е. Терапевтическая эквивалентность, биоэквивалентность и взаимозаменяемость лекарственных средств. Врач. 2015; (10): 32-5. [Sokolov A., Kukes V., Bunatyan N., Rodina T., Prokofiev A., Arkhipov V., Krasnykh L., Sokova E. Therapeutic equivalence, bioequivalence and interchangeability of medicinal products. Vrach. 2015; (10): 32-5. (in Russian)].
  67. Стандартный образец Dydrogesterone EP CRS, № Y0001004. [Y0001004 Dydrogesterone European Pharmacopoeia (EP) Reference Standard].
  68. Стандартный образец USP RS Dydrogesterone (9β,10α-Pregna-4,6-diene-3,20-dione), USP Catalog No.: 1231003, USP Lot No.: R161T0. [USP Reference Standart Dydrogesterone (9β,10α-Pregna-4,6-diene-3,20-dione), USP Catalog No.: 1231003, USP Lot No.: R161T0].
  69. Zarei A., Sohail P., Parsanezhad M.E., Alborzi S., Samsami A., Azizi M. Comparison of four protocols for luteal phase support in frozen-thawed embryo transfer cycles: a randomized clinical trial. Arch. Gynecol. Obstet. 2017;295(1): 239-46. https://dx.doi.org/10.1007/s00404-016-4217-4.
  70. New M.I., Ghizzoni L., Meyer-Bahlburg H., Khattab A., Reichman D., Rosenwaks Z. Fertility in patients with nonclassical congenital adrenal hyperplasia. Fertil. Steril. 2019; 111(1): 13-20. https://dx.doi.org/10.1016/j.fertnstert.2018.11.023.
  71. Pavlidi O., Kolibianakis E.M. Fertility treatment in women with classical and nonclassical congenital adrenal hyperplasia. In: Ertorer M.E., eds. Fertility and reproductive outcomes in different forms of congenital adrenal hyperplasia. Springer, Cham. 2021. https://dx.doi.org/10.1007/978-3-030-82591-1_8.
  72. Инструкция по медицинскому применению лекарственного препарата Преднизолон, таблетки 5 мг, ЛП-№(002720)-(РГ-RU) от 10.07.2023. [Instructions for the medical use of the drug Prednisolone tablets 5 mg, LP-No.(002720)-(RG-RU) dated 10/07/2023. (in Russian)].
  73. Инструкция по медицинскому применению лекарственного препарата Метипред, таблетки 4 мг, П 015709/01 от 25.01.2024. [Instructions for the medical use of the drug Metypred tablets 4 mg, P 015709/01 dated 25/01/2024. (in Russian)].
  74. Slob E.M.A.., Termote J.U.M., Nijkamp J.W., van der Kamp H.J., van den Akker E.L.T. Safety of antenatal predniso(lo)ne and dexamethasone on fetal, neonatal and childhood outcomes: a systematic review. J. Clin. Endocrinol. Metab. 2024; 109(4): e1328-e1335. https://dx.doi.org/10.1210/clinem/dgad547.
  75. Taylor P.N., Minassian C., Rehman A., Iqbal A., Draman M.S., Hamilton W. et al. TSH levels and risk of miscarriage in women on long-term levothyroxine: a community-based study. J. Clin. Endocrinol. Metab. 2014; 99(10): 3895-902. https://dx.doi.org/10.1210/jc.2014-1954.
  76. Kuroda K., Ikemoto Y., Horikawa T., Moriyama A., Ojiro Y., Takamizawa S. et al. Novel approaches to the management of recurrent pregnancy loss: The OPTIMUM (OPtimization of Thyroid function, Thrombophilia, Immunity, and Uterine Milieu) treatment strategy. Reprod. Med. Biol. 2021; 20(4): 524-36. https://dx.doi.org/10.1002/rmb2.12412.
  77. Общая характеристика лекарственного препарата L-Тироксин 50 Берлин-Хеми, 50 мкг, таблетки, ЛП-№(006003)-(РГ-RU) от 26.06.2024. [Product Characteristics of L-Thyroxin 50 Berlin-Chemie 50 µg tablets, LP-No.(006003)-(RG-RU) dated 26/06/2024 (in Russian)].
  78. Sankoda A., Suzuki H., Imaizumi M., Yoshihara A., Kobayashi S., Katai M. et al. Effects of levothyroxine treatment on fertility and pregnancy outcomes in subclinical hypothyroidism: a systematic review and meta-analysis of randomized controlled trials. Thyroid. 2024; 34(4): 519-30. https://dx.doi.org/10.1089/thy.2023.0546.
  79. Gottwald-Hostalek U., Kahaly G.J. Optimizing levothyroxine treatment for subclinical hypothyroidism during pregnancy. Curr. Med. Res. Opin. 2024; 40(1): 43-9. https://dx.doi.org/10.1080/03007995.2023.2276120.
  80. Leng T., Li X., Zhang H. Levothyroxine treatment for subclinical hypothyroidism improves the rate of live births in pregnant women with recurrent pregnancy loss: a randomized clinical trial. Gynecol. Endocrinol. 2022; 38(6): 488-94. https://dx.doi.org/10.1080/09513590.2022.2063831.
  81. Luo J., Yuan J. Effects of levothyroxine therapy on pregnancy and neonatal outcomes in subclinical hypothyroidism. Int. J. Gen. Med. 2022; 15: 6811-20. https://dx.doi.org/10.2147/IJGM.S366981.
  82. Дедов И.И., Шестакова М.В., Майоров А.Ю., ред. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 11-й выпуск. М.; 2023: 148-61. [Dedov I.I., Shestakova M.V., Mayorov A.Yu., eds. Standards of specialized diabetes care. 11th Edition. Moscow; 2023: 148-61. (in Russian)].
  83. Дедов И.И., Мельниченко Г.А., Бурумкулова Ф.Ф., ред. Эндокринные заболевания и беременность в вопросах и ответах. Руководство для врачей. М.: Е-ното; 2024. 336 с. [Dedov I.I., Melnichenko G.A., Burumkulova F.F., ed. Endocrine diseases and pregnancy in questions and answers. A guide for doctors. M.: E-noto; 2024. 336 p. (in Russian)].
  84. Дедов И.И., Шестакова М.В., Майоров А.Ю., Шамхалова М.Ш., Сухарева О.Ю., Галстян Г.Р., Токмакова А.Ю., Никонова Т.В., Суркова Е.В., Кононенко И.В., Егорова Д.Н., Ибрагимова Л.И., Шестакова Е.А., Клефортова И.И., Скляник И.А., Ярек-Мартынова И.Я., Северина А.С., Мартынов С.А., Викулова О.К., Калашников В.Ю., Бондаренко И.З., Гомова И.С., Старостина Е.Г., Аметов А.С., Анциферов М.Б., Бардымова Т.П., Бондарь И.А., Валеева Ф.В., Демидова Т.Ю., Мкртумян А.М., Петунина Н.А., Руяткина Л.А., Суплотова Л.А., Ушакова О.В., Халимов Ю.Ш. Сахарный диабет 2 типа у взрослых. Сахарный диабет. 2020; 23(2S): 4-102. [Dedov I.I., Shestakova M.V., Mayorov A.Y., Shamkhalova M.S., Sukhareva O.Yu., Galstyan G.R., Tokmakova A.Y., Nikonova T.V., Surkova E.V., Kononenko I.V., Egorova D.N., Ibragimova L.I., Shestakova E.A., Klefortova I.I., Sklyanik I.A., Yarek-Martynova I.Ya., Severina A.S., Martynov S.A., Vikulova O.K., Kalashnikov V.Y., Bondarenko I.Z., Gomova I.S., Starostina E.G., Ametov A.S., Antsiferov M.B., Bardymova T.P., Bondar I.A., Valeeva F.V., Demidova T.Y., Mkrtumyan A.M., Petunina N.A., Ruyatkina L.A., Suplotova L.A., Ushakova O.V., Khalimov Yu.Sh. Diabetes mellitus type 2 in adults. Diabetes mellitus. 2020; 23(2S): 4-102. (in Russian)]. https://dx.doi.org/10.14341/DM12507.
  85. Инструкция по медицинскому применению лекарственного препарата НовоРапид® Пенфилл® от 24.01.2020. [Instructions for the medical use of the drug NovoRapid® Penfill® dated 24/01/2020. (in Russian)].
  86. Общая характеристика лекарственного препарата Лантус® СолоСтар®, 100 ЕД/мл, раствор для подкожного введения, ЛП-№(000207)-(РГ-RU) от 13.06.2024. [Product Characteristics of Lantus® SoloStar® 100 U/mL solution for subcutaneous injection, LP-No.(000207)-(RG-RU) dated 13/06/2024. (in Russian)].
  87. Feig D.S., Donovan L.E., Corcoy R., Murphy K.E., Amiel S.A., Hunt K.F. et al.; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017; 390 (10110): 2347-59. https://dx.doi.org/10.1016/S0140-6736(17)32400-5.
  88. Lemaitre M., Faiz K., Baudoux F., Subtil D., Vambergue A. Intermittently scanned continuous glucose monitoring is associated with lower spontaneous abortion rate compared with conventional blood glucose monitoring in pregnant women with type 1 diabetes: An observational study. Diab. Vasc. Dis. Res. 2022; 19(6): 14791641221136837. https://dx.doi.org/10.1177/14791641221136837.
  89. Majewska A., Stanirowski P.J., Tatur J., Wojda B., Radosz I., Wielgos M. et al. Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial. Acta Diabetol. 2023; 60(9): 1171-7. https://dx.doi.org/10.1007/s00592-023-02091-2.
  90. García-Moreno R.M., Benítez-Valderrama P., Barquiel B., González Pérez-de-Villar N., Hillman N., Lora Pablos D. et al. Efficacy of continuous glucose monitoring on maternal and neonatal outcomes in gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials. Diabet Med. 2022; 39(1): e14703. https://dx.doi.org/10.1111/dme.14703.
  91. Scott E.M., Bilous R.W., Kautzky-Willer A. Accuracy, user acceptability, and safety evaluation for the FreeStyle Libre Flash Glucose Monitoring System when used by pregnant women with diabetes. Diabetes Technol. Ther. 2018; 20(3): 180-8. https://dx.doi.org/10.1089/dia.2017.0386.
  92. Федеральная служба государственной статистики (Росстат). https://rosstat.gov.ru/folder/12781 [Federal State Statistics Service (Rosstat). https://rosstat.gov.ru/folder/12781 (in Russian)].
  93. Christianson A. Howson C.P., Modell B. March of Dimes Global Report of Birth Defects: The Hidden Toll of Dying and Disabled Children. White Plains, New York; 2006.
  94. ВРТ: выбор стратегии. Инновационная фармакотерапия. 2021; 3: 30-4. [ART: choosing a strategy. Innovative pharmacotherapy. 2021; 3: 30-4. (in Russian)].
  95. Репродуктология: Поиск инновационных решений. Инновационная фармакотерапия. 2022; 5(9): 32-8. [Reproductology: Search for innovative solutions. Innovative pharmacotherapy. 2022; 5(9): 32-8. (in Russian)].
  96. Кузнецова И.В., Григорян А.Н., Геппе Н.А., Коваль-Зайцев А.А. Особенности психосексуального развития детей, рожденных женщинами, получавшими гормональную терапию во время беременности. Гинекология. 2015; 17(2): 45-9. [Kuznetsova I.V., Grigoryan A.N., Geppe N.A., Kovsal-Zaytsev A.A. Features of the psychosexual development of children born to women who received hormonal treatment during pregnancy. Gynecology. 2015; 17(2): 45-9. (in Russian)].
  97. Серов В.Н., Назаренко Т.А., Тапильская Н.И., Тетруашвили Н.К., Ших Е.В. Безопасность гестагенов при лечении бесплодия и во время беременности: новые данные в 2023 г. Заключение экспертов Российского общества акушеров-гинекологов. Акушерство и гинекология. 2023; 8: 236-9. [Serov V.N., Nazarenko T.A., Tapilskaya N.I., Tetruashvili N.K., Shikh E.V. Progestogens safety in the treatment of infertility and during pregnancy: new data in 2023. Position of the Russian Society of Obstetricians and Gynecologists. Obstetrics and Gynecology. 2023; (8): 236-9. (in Russian)]. https://dx.doi.org/10.18565/aig.2023.196.

About the Authors

Gennady T. Sukhikh, Dr. Med. Sci., Professor, Academician of RAS, Director of the Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-18-00, g_sukhikh@oparina4.ru
Vladimir N. Serov, Dr. Med. Sci., Professor, Academician of RAS, President of Russian Society of Obstetricians and Gynecologists; Chief Scientific Consultant,
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), +7(495)531-44-44,
v_serov@oparina4.ru
Natalia V. Artymuk, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology named after Prof. G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of Russia (Kemerovo), +7(3842)73-48-56, +7(960)923-33-55, artymuk@gmail.com
Marina I. Bazina, Dr. Med. Sci., Professor, Chief Freelance Specialist in Reproductive Health of the Ministry of Health of the Krasnoyarsk Territory; Head of the Department of Obstetrics and Gynecology, Institute of Postgraduate Education, Krasnoyarsk State Medical University named after. Prof. V.F. Voino-Yasenetsky Ministry of Health of Russia (Krasnoyarsk)
Margarita D. Andreeva, Dr. Med. Sci., Professor at the Department of Obstetrics, Gynecology and Perinatology of the Faculty of Advanced Training and Teaching Staff,
Kuban State Medical University, Ministry of Health of Russia (Krasnodar), andreeva_md@mail.ru
Igor I. Baranov, Dr. Med. Sci., Professor, Head of the Scientific and Educational Program Department, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow). +7(495)438-94-92, i_baranov@oparina4.ru
Nadezhda V. Bashmakova, Dr. Med. Sci., Professor, Honored Doctor of the Russian Federation, Chief Researcher of Ural Research Institute of Maternity and Child Care, Ministry of Health of Russia; Chief Obstetrician-Gynecologist of the Ural Federal District (Yekaterinburg), +7(343)371-87-68, BashmakovaNV@niiomm.ru
Vitalii F. Bezhenar, Dr. Med. Sci., Professor, Head of the Department of Obstetrics, Gynecology and Neonatology, Head of the Department of Obstetrics, Gynecology and Reproductology, Head of the Clinic of Obstetrics and Gynecology, Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia; Chief Freelance Specialist in Obstetrics and Gynecology (St. Petersburg), +7(812)338-67-44, bez-vitaly@yandex.ru
Larisa D. Belotserkovtseva, Dr. Med. Sci., Professor, Honored Doctor of the Russian Federation, Head of the Department of Obstetrics, Gynecology and Perinatology of the Medical Institute, Surgut State University; Chief Physician, Surgut Clinical Perinatal Center (Surgut), ag_kpc@admsurgut.ru
Natalya A. Geppe, Dr. Med. Sci., Professor, Head of the Department of Pediatric Diseases, Clinical Institute of Children’s Health named after N.F. Filatov, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University) (Moscow), geppe@mail.ru
Natalia V. Dolgushina, Dr. Med. Sci., Professor, Deputy Director – Head of the Department of the Organization of the Scientific Activities, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-49-77 (1362), n_dolgushina@oparina4.ru
Nadezhda V. Zaretskaya, PhD, Head of the Laboratory of Clinical Genetics, Institute of Reproductive Genetics, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), n_zaretskaya@oparina4.ru
Irina N. Zakharova, Dr. Med. Sci., Professor, Head of the Department of Pediatrics, Russian Medical Academy of Professional Education, Ministry of Health of Russia;
Chief Pediatrician of the Central Federal District of Russia, Honored Doctor of the Russian Federation (Moscow), +7(495) 495-52-38, E-mail: zakharova-rmapo@yandex.ru
Viktor V. Zubkov, Dr. Med. Sci., Director of the Institute of Neonatology and Pediatrics, Head of the Department of Neonatology, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia; Professor at the Department of Neonatology, N.F. Filatov Clinical Institute of Children’s Health, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University) (Moscow), v_zubkov@oparina4.ru
Elena V. Enkova, Dr. Med. Sci., Professor at the Department of Obstetrics and Gynecology No. 2, N.N. Burdenko Voronezh State Medical University, Ministry of Health of Russia (Voronezh), enkova@bk.ru
Roza M. Yesayan, PhD, Head of the Therapeutic Department, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), rozaes@mail.ru
Nadezhda Yu. Katkova, Dr. Med. Sci., Associate Professor at the Department of Obstetrics and Gynecology, Faculty of Additional Professional Education, Privolzhsky Research Medical University, Ministry of Health of Russia (Nizhny Novgorod), katkova_nu@inbox.ru
Elena V. Kvashnina, PhD, Reprduktologist, Deputy Director for Medical Affairs, Center IVF Partus Clinic (Yekaterinburg), +7(343)385-57-38, centreko@ivf-partus.ru
Igor Yu. Kogan, Dr. Med. Sci., Professor, Corresponding Member of RAS, Director of D.O. Ott Scientific Research Institute of Obstetrics, Gynecology and Reproductology
(St. Petersburg), +7(812)679-55-51, iagmail@ott.ru
Vladislav S. Korsak, Dr. Med. Sci., Professor, President of RARH; General Director of JSC International Center for Reproductive Medicine (Saint-Petersburg),
+7(812)385-69-85, ivf@mcrm.ru
Ksenia V. Krasnopolskaya, Corresponding Member of RAS, Dr. Med. Sci., Professor, Head of the Department of Assisted Reproductive Technologies, MONIIAG;
Medical Director of Prior Clinic LLC (Moscow), guzmoniiag@gmail.com
Irina I. Kukarskaya, Dr. Med. Sci., Professor, Chief Freelance Specialist in Obstetrics and Gynecology of the Department of Health of the Tyumen Region; Head of the Department of Obstetrics, Gynecology and Perinatology of the Institute of Maternity and Childhood, Tyumen State Medical University, Ministry of Health of Russia;
Chief Physician of the Tyumen Regional Perinatal Center, Honored Doctor of the Russian Federation (Tyumen), kukarskay@mail.ru
Irina V. Molchanova, PhD, Chief Physician, Altai Regional Clinical Perinatal Center; Chief Freelance Specialist in Obstetrics and Gynecology in the Altai Territory (Barnaul), +7(903)949-10-64, molcanova2008@yandex.ru
Tatiana A. Nazarenko, Dr. Med. Sci., Professor, Director of the Institute of Reproductive Medicine, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), +7(495)531-44-44, t_nazarenko@oparina4.ru
Tatiana I. Pestova, PhD, Head of the Department of Assisted Reproductive Technologies, Regional Perinatal Center, Chelyabinsk; Chief Freelance Specialist in Reproductive Health of the Ministry of Health of the Chelyabinsk Region, +7(912)790-88-24, glav_vrach6767@mail.ru
Natalia M. Podzolkova, Dr. Med. Sci., Professor, Head of Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia (Moscow), +7(499)748-15-30, podzolkova@gmail.com
Irina V. Saveljeva, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 1, Omsk State Medical University, Ministry of Health of Russia;
Chief Freelance Specialist in Obstetrics and Gynecology of the Ministry of Health of the Omsk region (Omsk), +7(913)654-35-77, saveljeva_iv_omsk@mail.ru
Anna I. Sazonova, PhD, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), anyta_sazonova@mail.ru
Yuri A. Semenov, PhD, Chief Physician, Regional Perinatal Center; Chief Freelance Obstetrician-Gynecologist of Ministry of Health of Chelyabinsk Region (Chelyabinsk)
Natalia I. Tapilskaya, Dr. Med. Sci., Professor, Leading Researcher at the Department of Assisted Reproductive Technologies, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology (St. Petersburg), +7(921)933-61-26, tapnatalia@yandex.ru
Nana K. Tetruashvili, Dr. Med. Sci., Head of the 2nd Obstetric Department of Pregnancy Pathology, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), tetrauly@mail.ru
Alena V. Tiselko, Dr. Med. Sci., Leading Researcher at the Department of Endocrinology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
(St. Petersburg), alenadoc@mail.ru
Valentin V. Fadeev, Corresponding Member of RAS, Dr. Med. Sci., Professor, Head of the Department of Endocrinology, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University) (Moscow), walfad@mail.ru
Nato L. Shamugia, PhD, Associate Professor at the Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education,
Ministry of Health of Russia; Member of the RAHR Education Committee; Member of the European Society for Human Reproduction and Embryology (ESHRE) (Moscow).
Marina A. Shakhova, Dr. Med. Sci., Head of the Department of Quality Assurance at ART, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow), +7(495)53144-44, m_shakhova@oparina4.ru
Evgenija V. Shikh, Dr. Med. Sci., Professor; Director of Institute of Professional education, Head of the Department of Clinical Pharmacology, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University) (Moscow), +7(499)248-05-53, chih@mail.ru
Maria I. Yarmolinskaya, Dr. Med. Sci., Professor of RAS, Head of the Department of Gynecology and Endocrinology, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology; Professor at the Department of Obstetrics and Gynecology, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia (St. Petersburg), m.yarmolinskaya@gmail.com
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