Predictors of pregnancy rate in assisted reproductive technologies: results of the iris observational program in the population of Russia and Kazakhstan

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Abstract

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.

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About the authors

Tatiana A. Nazarenko

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Author for correspondence.
Email: t_nazarenko@oparina4.ru

Dr. Med. Sci., Professor, Director of the Institute of Reproductive Medicine

 

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Tatiana I. Pestova

Regional Perinatal Center

Email: glav_vrach6767@mail.ru

PhD, Head of the Department of Assisted Reproductive Technologies, Chief Freelance Specialist in Reproductive Health

Chelyabins

Vyacheslav N. Lokshin

National Academy of Sciences of the Republic of Kazakhstan; International Academy of Reproductology; PERSONA International Clinical Center for Reproductology

Email: v_lokshin@persona-ivf.kz
ORCID iD: 0000-0002-4792-5380

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

Kazakhstan, Almaty; Almaty; Almaty

Tamara M. Dzhusubalieva

Institute of Reproductive Medicine

Email: tamara_kmpa@mail.ru

PhD, CEO of the IRM Clinic, obstetrician-gynecologist of the highest category, WHO expert on reproductive health

Kazakhstan, Almaty

Vladimir N. Serov

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: v_serov@oparina4.ru

Dr. Med. Sci., Professor, Academician of RAS, President of the Russian Society of Obstetricians and Gynecologists, Chief Scientific Consultant

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Igor I. Baranov

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: i_baranov@oparina4.ru

Dr. Med. Sci., Professor, Head of the Department of Scientific and Educational Programs

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Vitaly F. Bezhenar

I.P. Pavlov First St. Petersburg State Medical University, Ministry of Health of Russia

Email: bez-vitaly@yandex.ru

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, Chief Freelance Specialist in Obstetrics and Gynecology

Russian Federation, St. Petersburg

Alla A. Gavisova

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: a_gavisova@oparina4.ru

Dr. Med. Sci., Head of the 1st Gynecological Department

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Elena A. Gorodnova

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: e_gorodnova@oparina4.ru

PhD, Head of the Center for Scientific and Clinical Research

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Natalia V. Dolgushina

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: n_dolgushina@oparina4.ru

Dr. Med. Sci., Professor, Deputy Director for Research

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

Alla S. Kalugina

I.P. Pavlov First St. Petersburg State Medical University, Ministry of Health of Russia

Email: alla19021962@gmail.com

Dr. Med. Sci., Professor, Professor at the Department of Obstetrics, Gynecology and Neonatology, Chief Freelance Specialist in Women’s Reproductive Health of the Ministry of Health of Russia in the North-Western Federal District

Russian Federation, St. Petersburg

Elena V. Kvashnina

IVF Center Partus Clinic

Email: centreko@ivf-partus.ru

PhD, Reproductologist, Deputy Director for Medical Affairs

Russian Federation, Yekaterinburg

Igor Yu. Kogan

D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology

Email: iagmail@ott.ru

Dr. Med. Sci., Professor, Corresponding Member of RAS, Director

Russian Federation, St. Petersburg

Yulia A. Koloda

Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia
Life Line Reproduction Center

Email: julkol@yandex.ru

PhD, Associate Professor, Department of Obstetrics and Gynecology, Obstetrician-Gynecologist, Medical Director of the «Life Line» Reproduction Center, Member of ESHRE and Chairman of the RAHR Committee

Russian Federation, Moscow; Moscow

Vladislav S. Korsak

International Center for Reproductive Medicine

Email: ivf@mcrm.ru

Dr. Med. Sci., Professor, President of the RAHR; General Director

Russian Federation, St. Petersburg

Ksenia V. Krasnopolskaya

Academician V.S. Krasnopolsky Moscow Regional Research Institute of Obstetrics and Gynecology; Prior Clinic LLC

Email: guzmoniiag@gmail.com

Dr. Med. Sci., Corresponding Member of RAS, Professor, Head of the Department of Assisted Reproductive Technologies, Medical Director Clinic

Russian Federation, Moscow; Moscow

Irina V. Molchanova

Altai Regional Clinical Perinatal Center

Email: molcanova2008@yandex.ru

PhD, Chief Physician, Chief Freelance Specialist in Obstetrics and Gynecology in the Altai Territory

Russian Federation, Barnaul

Venera L. Sabirova

Institute of Fundamental Medicine and Biology Kazan Federal University; Reproductive clinic "Scandinavia (AVA-Kazan)"

Email: sabirova-vl@avaclinic.ru

PhD, Head of the IVF Department, Senior Lecturer

Russian Federation, Kazan; Kazan

Natalya I. Tapilskaya

D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology

Email: tapnatalia@yandex.ru

Dr. Med. Sci., Professor, Head of the Department of Reproductology

Russian Federation, St. Petersburg

Gennady T. Sukhikh

Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: g_sukhikh@oparina4.ru

Dr. Med. Sci., Professor, Academician of RAS, Director

Russian Federation, 4, Ac. Oparin str., Moscow, 117997

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Supplementary files

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2. Fig. 1. Block diagram of the analyzed populations

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3. Fig. 2. Predictors and probability of clinical pregnancy in the final 5-factor model

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4. Fig. 3. Predictors and probability of clinical pregnancy in the final 5-factor model in the Russian subpopulation

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