Predictors of pregnancy rate in assisted reproductive technologies: results of the IRIS observational program in the population of Russia and Kazakhstan
Nazarenko T.A., Pestova T.I., Lokshin V.N., Dzhusubalieva T.M., Serov V.N., Baranov I.I., Bezhenar V.F., Gavisova A.A., Gorodnova E.A., Dolgushina N.V., Kalugina A.S., Kvashnina E.V., Kogan I.Yu., Koloda Yu.A., Korsak V.S., Krasnopolskaya K.V., Molchanova I.V., Sabirova V.L., Tapilskaya N.I., Sukhikh G.T.
Objective: To evaluate the predictors of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) success in females receiving oral dydrogesterone for luteal phase support with subsequent evaluation of the relationship between influencing factors and pregnancy rates, and the creation for the first time of a prognostic table for clinical pregnancy in IVF and ICSI cycles, identifying the most influential predictors.
Materials and methods: Multicenter open-label observational program for assessing the probability of pregnancy in IVF cycles enrolled females who were prescribed dydrogesterone 30 mg a day for luteal phase support while undergoing assisted reproductive technology in routine setting of Russia and Kazakhstan according to the national guidelines. The primary objective of the study was to evaluate the predictors of pregnancy rate in IVF and ICSI, followed by the creation of a prognostic table of clinical pregnancy in IVF and ICSI cycles considering 4–5 most significant predictors. Secondary objectives assessed included biochemical and clinical pregnancy rates, convenience and overall satisfaction with therapy, live birth, and maternal and fetal safety were also assessed.
Results: 1150 patients were enrolled from 42 study sites in the Russian Federation and 2 study sites in the Republic of Kazakhstan.
1146/1150 (99.7%) patients were exposed to Duphaston and constituted the safety set, out of them 534 patients were from the IVF subgroup, and 612 patients were from the ICSI subgroup. 1143/1150 (99.4%) patients constituted the full analysis set (994 from Russia and 149 from Kazakhstan) with a median age of 34 years. Clinical pregnancy rate was 36.7% and the live birth rate was 30.1%. The collected data has been used to build a clinical pregnancy rate prediction model. According to the prediction model, the best pregnancy probability while taking dydrogesterone would be for females under 37 years of age with antral follicle count of ≤12 and top-quality embryos, for whom IVF would be used. The study confirmed a high level of satisfaction with dydrogesterone therapy. In the study population dydrogesterone showed a favorable safety profile for fetus/newborn and mothers.
Conclusion: Results of the study provide the practical a robust predictive model for IVF/ICSI success while demonstrating favorable oral dydrogesterone efficacy and safety profiles in routine practice.
Authors’ contributions: Nazarenko T.A., Pestova T.I., Lokshin V.N., Dzhusubalieva T.M., Serov V.N., Baranov I.I., Bezhenar V.F., Gavisova A.A., Gorodnova E.A., Dolgushina N.V., Kalugina A.S., Kvashnina E.V., Kogan I.Yu., Koloda Yu.A., Korsak V.S., Krasnopolskaya K.V., Molchanova I.V., Sabirova V.L., Tapilskaya N.I., Sukhikh G.T. – developing the conception and design of the study, collecting and processing the material, writing the text, editing the article.
Conflicts of interest: The authors declare no conflicts of interest.
Funding: The prospective data collection and medical writing support were provided with support by Abbott Laboratories LLC.
Acknowledgements: The authors would like to thank the researchers presented below:
D.P. Kamilova, T.V. Kaznacheeva, I.M. Zorina, L.B. Kindarova, L.R. Khechumyan, Yu.A. Fetisova, E.Sh. Ablyaeva, E.N. Gavrilina, N.V. Shilova (Moscow); O.E. Vasilyeva, A.G. Tkachuk, D.A. Gerculov, E.V. Zhigalova, S.V. Nikitin
(St. Petersburg); A.V. Mukhina (Volgograd); I.N. Korotkikh (Voronezh); N.V. Bashmakova (Yekaterinburg); S.S. Semenenko, Yu.N. Zholobov (Ivanovo); E.B. Druzhinina, A.V. Khoroshavina (Irkutsk); Yu.Yu. Borodina, A.I. Abitova (Kazan); V.A. Popandupulo, O.Yu. Kostrikova (Krasnodar); T.V. Gvozdikova (Lipetsk); E.V. Kuznetsova (Novosibirsk); M.M. Ovchinnikova (Odintsovo); O.V. Fotina (Perm); I.V. Moiseeva (Samara); K.V. Artemenko (Saratov); E.M. Kasparova (Stavropol); Zh.F. Gaifulina (Tomsk); E.E. Privalova, N.Yu. Likhacheva, E.V. Orekhova (Chelyabinsk); Sh.K. Karibaeva, A.T. Abshekenova, R.K. Valiev, V.A. Nekhorosheva (Almaty).
Assistance in the preparation of this publication was provided by the Medical Advisor group, represented by Yakov Pakhomov and Nikolai Tabakaev.
Ethical Approval: The study design and documents were reviewed and approved by national ethics committees of the clinical centres from the Russian Federation. In Kazakhstan, ethical review and approval was provided by the Central Bioethics Commission at the Salidat Kairbekova National Research Center for Health Development; the approval by national ethics committees was optional.
Patient Consent for Publication: The patients signed an informed consent form to participate in the study.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator (Nazarenko T.A.).
For citation: Nazarenko T.A., Pestova T.I., Lokshin V.N., Dzhusubalieva T.M., Serov V.N., Baranov I.I., Bezhenar V.F., Gavisova A.A., Gorodnova E.A., Dolgushina N.V., Kalugina A.S., Kvashnina E.V., Kogan I.Yu., Koloda Yu.A.,
Korsak V.S., Krasnopolskaya K.V., Molchanova I.V., Sabirova V.L., Tapilskaya N.I., Sukhikh G.T.
Predictors of pregnancy rate in assisted reproductive technologies: results of the IRIS observational program
in the population of Russia and Kazakhstan.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; 3: 144-158 (in Russian)
https://dx.doi.org/10.18565/aig.2025.82
Keywords
assisted reproductive technology
in vitro fertilization
intracytoplasmic sperm injection
IVF
ICSI
dydrogesterone
predictive model
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Received 21.03.2025
Accepted 27.03.2025
About the Authors
Tatiana A. Nazarenko, Dr. Med. Sci., Professor, Director of the Institute of Reproductive Medicine, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)531-44-44, t_nazarenko@oparina4.ruTatiana 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
Vyacheslav N. Lokshin, Academician of the National Academy of Sciences of the Republic of Kazakhstan, Professor, Chief Reproductive Specialist of the Ministry of Health of the Republic of Kazakhstan; President of the Kazakhstan Association of Reproductive Medicine; President of the International Academy of Reproductology; General Director of the PERSONA International Clinical Center for Reproductology (Almaty), +7(701)755-82-09, v_lokshin@persona-ivf.kz, https://orcid.org/0000-0002-4792-5380
Tamara M. Dzhusubalieva, PhD, CEO of the IRM Clinic, obstetrician-gynecologist of the highest category, WHO expert on reproductive health (Almaty),
+7(701)111-34-37, tamara_kmpa@mail.ru
Vladimir N. Serov, Dr. Med. Sci., Professor, Academician of RAS, President of the Russian Society of Obstetricians and Gynecologists, Chief Scientific Consultant, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)531-44-44, v_serov@oparina4.ru
Igor I. Baranov, Dr. Med. Sci., Professor, Head of the Department of Scientific and Educational Programs, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-94-92, i_baranov@oparina4.ru
Vitaly 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, Academician I.P. Pavlov First St. Petersburg State Medical University, Ministry of Health of Russia;
Chief Freelance Specialist in Obstetrics and Gynecology of the Health Committee of St. Petersburg (St. Petersburg), +7(812)338-67-44, bez-vitaly@yandex.ru
Alla A. Gavisova, Dr. Med. Sci., Head of the 1st Gynecological Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)531-44-44, a_gavisova@oparina4.ru
Elena A. Gorodnova, PhD, Head of the Center for Scientific and Clinical Research, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology
and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-94-92, e_gorodnova@oparina4.ru
Natalia V. Dolgushina, Dr. Med. Sci., Professor, Deputy Director for Research, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-49-77 (1362), n_dolgushina@oparina4.ru
Alla S. Kalugina, Dr. Med. Sci., Professor, Professor at the Department of Obstetrics, Gynecology and Neonatology, Academician I.P. Pavlov First St. Petersburg State Medical University, Ministry of Health of Russia; Chief Freelance Specialist in Women’s Reproductive Health of the Ministry of Health of Russia in the North-Western Federal
District (St. Petersburg), alla19021962@gmail.com
Elena V. Kvashnina, PhD, Reproductologist, Deputy Director for Medical Affairs, IVF Center 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 the D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
(St. Petersburg), +7(812)679-55-51, iagmail@ott.ru
Yulia A. Koloda, PhD, Associate Professor, Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education; Obstetrician-Gynecologist, Medical Director of the «Life Line» Reproduction Center; Member of ESHRE and Chairman of the RAHR Committee (Moscow), julkol@yandex.ru
Vladislav S. Korsak, Dr. Med. Sci., Professor, President of the RAHR; General Director of International Center for Reproductive Medicine JSC (St. Petersburg),
+7(812)385-69-85, ivf@mcrm.ru
Ksenia V. Krasnopolskaya, Dr. Med. Sci., Corresponding Member of RAS, Professor, Head of the Department of Assisted Reproductive Technologies,
Academician V.S. Krasnopolsky Moscow Regional Research Institute of Obstetrics and Gynecology; Medical Director, Clinic Prior LLC (Moscow), guzmoniiag@gmail.com
Irina V. Molchanova, PhD, Chief Physician of the 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
Venera L. Sabirova, PhD, Head of the IVF Department, «Scandinavia (AVA-Kazan» Reproduction Clinic; Senior Lecturer, Institute of Fundamental Medicine and Biology (Kazan), sabirova-vl@avaclinic.ru
Natalya I. Tapilskaya, Dr. Med. Sci., Professor, Head of the Department of Reproductology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
(St. Petersburg), +7(921)933-61-26, tapnatalia@yandex.ru
Gennady T. Sukhikh, Dr. Med. Sci., Professor, Academician of RAS, Director of the Academician V.I. Kulakov National Medical Research Center for Obstetrics,
Gynecology and Perinatology, Ministry of Health of Russia (Moscow), +7(495)438-18-00, g_sukhikh@oparina4.ru
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