Resolution of the Council of experts in obstetrics and gynecology "New possibilities of luteal phase support with progesterone preparations in the framework of import substitution"

Korneeva I.E., Kamilova D.P., Tapilskaya N.I., Mayasina E.N., Fatkullina L.S., Chibisova A.N., Garayeva G.V., Lazareva L.M.

April 25, 2023, Moscow

Council of experts: Korneeva I.E., Kamilova D.P., Tapilskaya N.I., Mayasina E.N., Fatkullina L.S., Chibisova A.N., Garayeva G.V., Lazareva L.M.

For citation: Korneeva I.E., Kamilova D.P., Tapilskaya N.I., Mayasina E.N., Fatkullina L.S., Chibisova A.N., Garayeva G.V., Lazareva L.M. Resolution of the Council of experts in obstetrics and gynecology «New possibilities of luteal phase support with progesterone preparations in the framework of import substitution».
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2024; (1): 167-172 (in Russian)
https://dx.doi.org/10.18565/aig.2024.15

References

  1. van der Linden M., Buckingham K., Farquhar C., Kremer J.A., Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst. Rev. 2015; 2015(7): CD009154. https://dx.doi.org/10.1002/14651858.CD009154.pub3.
  2. Di Renzo G.C., Tosto V., Tsibizova V. Progesterone: History, facts, and artifacts. Best Pract. Res. Clin. Obstet. Gynaecol. 2020; 69: 2-12.https://dx.doi.org/10.1016/j.bpobgyn.2020.07.012.
  3. Piette P. The history of natural progesterone, the never-ending story. Climacteric. 2018; 21(4): 308-14. https://dx.doi.org/10.1080/13697137.2018.1462792.
  4. Large M.J., DeMayo F.J. The regulation of embryo implantation and endometrial decidualization by progesterone receptor signaling. Mol. Cell Endocrinol. 2012; 358(2): 155-65. https://dx.doi.org/10.1016/j.mce.2011.07.027.
  5. Labarta E., Rodríguez C. Progesterone use in assisted reproductive technology. Best Pract. Res. Clin. Obstet. Gynaecol. 2020; 69: 74-84. https://dx.doi.org/10.1016/j.bpobgyn.2020.05.005.
  6. Rosenberg S.M., Luciano A.A., Riddick D.H. The luteal phase defect: the relative frequency of, and encouraging response to, treatment with vaginal progesterone. Fertil. Steril. 1980; 34(1): 17-20. https://dx.doi.org/10.1016/s0015-0282(16)44831-4.
  7. Labarta E., Mariani G., Holtmann N., Celada P., Remohí J., Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum. Reprod. 2017; 32(12): 2437-42.https://dx.doi.org/10.1093/humrep/dex316. Erratum in: Hum. Reprod. 2018; 33(1): 178.
  8. Labarta E., Mariani G., Paolelli S., Rodriguez-Varela C., Vidal C., Giles J. et al. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum. Reprod. 2021; 36(3): 683-92. https://dx.doi.org/10.1093/humrep/deaa322.
  9. Melo P., Chung Y., Pickering O., Price M.J., Fishel S., Khairy M. et al. Serum luteal phase progesterone in women undergoing frozen embryo transfer in assisted conception: a systematic review and meta-analysis. Fertil. Steril. 2021; 116(6): 1534-56. https://dx.doi.org/10.1016/j.fertnstert.2021.07.002.
  10. Pabuçcu E., Pabuçcu R., Gürgan T., Tavmergen E. Luteal phase support in fresh and frozen embryo transfer cycles. J. Gynecol. Obstet. Hum. Reprod. 2020: 101838. https://dx.doi.org/10.1016/j.jogoh.2020.101838.
  11. Miles R.A., Paulson R.J., Lobo R.A., Press M.F., Dahmoush L., Sauer M.V. Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: a comparative study. Fertil. Steril. 1994; 62(3): 485-90. https://dx.doi.org/10.1016/s0015-0282(16)56935-0.
  12. Tavaniotou A., Smitz J., Bourgain C., Devroey P. Comparison between different routes of progesterone administration as luteal phase support in infertility treatments. Hum. Reprod. Update. 2000; 6(2): 139-48.https://dx.doi.org/10.1093/humupd/6.2.139.
  13. de Ziegler D., Sator M., Binelli D., Leuratti C., Cometti B., Bourgain C. et al. A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25 mg and 50 mg progesterone in aqueous preparation. Fertil. Steril. 2013; 100(3): 860-6. https://dx.doi.org/10.1016/j.fertnstert.2013.05.029.
  14. Ovarian Stimulation TEGGO, Bosch E., Broer S., Griesinger G., Grynberg M., Humaidan P., Kolibianakis E. et al. ESHRE guideline: ovarian stimulation for IVF/ICSI. Hum. Reprod. Open. 2020; 2020(2): hoaa009.https://dx.doi.org/10.1093/hropen/hoaa009. Erratum in: Hum. Reprod. Open. 2020; 2020(4): hoaa067.
  15. Shoham G., Leong M., Weissman A. A 10-year follow-up on the practice of luteal phase support using worldwide web-based surveys. Reprod. Biol. Endocrinol. 2021; 19(1): 15. https://dx.doi.org/10.1186/s12958-021-00696-2.
  16. Di Guardo F., Midassi H., Racca A., Tournaye H., De Vos M., Blockeel C. Luteal phase support in IVF: comparison between evidence-based medicine and real-life practices. Front. Endocrinol (Lausanne). 2020; 11: 500. https://dx.doi.org/10.3389/fendo.2020.00500.
  17. Министерство здравоохранения Российской Федерации. Клинические рекомендации «Женское бесплодие». 2021. [Ministry of Health of the Russian Federation. Clinical Guidelines “Women’s Infertility”. 2021.(in Russian)].
  18. Labarta E., Mariani G., Rodríguez-Varela C., Bosch E. Individualized luteal phase support normalizes live birth rate in women with low progesterone levels on the day of embryo transfer in artificial endometrial preparation cycles. Fertil. Steril. 2022; 117(1): 96-103. https://dx.doi.org/10.1016/j.fertnstert.2021.08.040.
  19. Tavaniotou A., Smitz J., Bourgain C., Devroey P. Comparison between different routes of progesterone administration as luteal phase support in infertility treatments. Hum. Reprod. Update. 2000; 6(2): 139-48.https://dx.doi.org/10.1093/humupd/6.2.139.
  20. Shiba R., Kinutani M., Okano S., Kawano R., Kikkawa Y. Efficacy of four vaginal progesterones for luteal phase support in frozen-thawed embryo transfer cycles: A randomized clinical trial. Reprod. Med. Biol. 2019; 19(1): 42-9.https://dx.doi.org/10.1002/rmb2.12300.
  21. Государственный реестр лекарственных средств РФ (ГРЛС). Инструкция по медицинскому применению препарата «Миражэль» [State Register of Medicines of the Russian Federation (GRLS). Instructions for the medical use of the drug «Miragel» (in Russian)]. https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=461e642f-e5e1-4af5-8e50-a7f25d670abd
  22. Simunic V., Tomic V., Tomic J., Nizic D. Comparative study of the efficacy and tolerability of two vaginal progesterone formulations, Crinone 8% gel and Utrogestan capsules, used for luteal support. Fertil. Steril. 2007; 87(1): 83-7. https://dx.doi.org/10.1016/j.fertnstert.2006.05.067. Erratum in: Fertil. Steril. 2007; 88(1): 254.
  23. Фармацевтическая компания «Вертекс». Информационное письмо №521 от 21.11.2023. [Pharmaceutical company «Vertex». Information letter No.521 dated 11/21/2023. (in Russian)]. https://vertex.spb.ru/upload/medialibrary/d70/e2hdrwmv8y2l6ro0lk6v6vanx5ipg9dj.pdf
  24. Тапильская Н.И., Гзгзян А.М., Коган И.Ю., Писарев В.В., Меркулов М.Е., Корнеева И.Е. Сравнительные фармакокинетические свойства и оценка безопасности воспроизведенного препарата прогестерона в форме вагинального геля: результаты открытого рандомизированного перекрестного исследования биоэквивалентности. Акушерство и гинекология. 2022; 8: 144-52. [Tapilskaya N.I., Gzgzyan А.М., Kоgan I.Yu., Pisarev V.V., Merkulov М.Е., Korneeva I.E. Pharmacokinetic properties and safety assessment of the generic vaginal gel progesterone preparation: results of an open-label, randomized, crossover bioequivalence study. Obstetrics and Gynecology. 2022; (8): 144-52 (in Russian)]. https://dx.doi.org/10.18565/aig.2022.8.144-152.
  25. Маясина Е.Н., Буев Ю.Е., Аскеров Р.А., Ямалыева Н.Ш., Кичигина Е.А., Корнилова А.С., Салимов Д.Ф. Сравнительный анализ эффективности вагинальных форм прогестерона в программах экстракорпорального оплодотворения. Проблемы репродукции. 2023; 29(5): 54-9. [Mayasina E.N., Buev Yu.E., Askerov R.A., Yamalyeva N.Sh., Kichigina E.A., Kornilova A.S., Salimov D.F. Comparative analysis of the effectiveness of vaginal forms of progesterone in IVF programs. Russian Journal of Human Reproduction. 2023; 29(5): 54-9. (in Russian)]. https://doi.org/10.17116/repro20232905154.
  26. Кедрова А.Г., Леваков С.А., Челнокова Н.Н., Ванке Н.С., Нечаева О.Е.Новые подходы к лечению простой гиперплазии эндометрия у женщин с предменструальным синдромом. Вопросы гинекологии, акушерства и перинатологии. 2014;13(1):22-9. [Kedrova A.G.,Levakov S.A., Chelnokova N.N., Vanke N.S., Nechaeva O.E. New approaches to treatment of simple endometrial hyperplasia in women with premenstrual syndrome. Gynecology, Obstetrics and Perinatology. 2014;13(1):22-9.(in Russian)].
  27. Средние цены в аптеках г. Москвы по данным агрегатора Ютека на 17.01.2024. [Average prices in pharmacies in Moscow according to the aggregator Yuteka on 17.01.2024. (in Russian)]. https://uteka.ru/catalog/

About the Authors

Irina E. Korneeva, Dr. Med. Sci., Professor, Senior Researcher, F. Paulsen Department of Fertility Preservation and Restoration, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia (Moscow).
Dilorom P. Kamilova, PhD, Member of the Russian Association of Human Reproduction, Member of the American and European Associations of Reproductive Medicine,
Chief IVF Specialist, MC GC «Mother and Child» (Moscow).
Natalya I. Tapilskaya, Dr. Med. Sci., Professor, Leading Researcher at the Department of Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; Professor at the Department of Obstetrics and Gynecology, St. Petersburg State Pediatric Medical University,
Ministry of Health of the Russia (St. Petersburg).
Elena N. Mayasina, PhD, obstetrician-gynecologist, Deputy General Director, LLC «Clinical Institute of Reproductive Medicine» (Yekaterinburg).
Larisa S. Fatkullina, PhD, Associate Professor, Department of Obstetrics and Gynecology named after Prof. V.S. Gruzdev, Kazan State Medical University, Ministry of Health of Russian Federation; Chief Freelance Specialist in Obstetrics and Gynecology of Kazan Department of Health of Ministry of Health of the Republic of Tatarstan (Kazan).
Angelina N. Chibisova, PhD, Associate Professor, Department of Obstetrics and Gynecology, TSU Medical Institute; obstetrician-gynecologist, Chief Physician, MC GK «Mother and Child» (LLC «Haven») (Tula).
Galina V. Garaeva, obstetrician-gynecologist, reproductologist, Head of the Department of ART, LLC «Clinic NGC» (Ufa).
Lyudmila M. Lazareva, PhD, obstetrician-gynecologist, gynecologist-endocrinologist, Research Center for Problems of Family Health and Human Reproduction (Irkutsk).
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