Lotus I: A Phase III randomized controlled trial of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization, with focus on the Russian subpopulation


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Abstract

Objective. Compare efficacy and safety of oral dydrogesterone (DYD) and micronized vaginal progesterone (MVP) for luteal support in IVF, with focus on Russian subjects. Subject and methods. Double-blind, randomized, multicenter non-inferiority study (Lotus I). Women undergoing IVF were randomized to DYD 10 mg or MVP 200 mg TID. Primary objective was the presence of fetal heartbeats at pregnancy week 10 (12 weeks’ gestation). Results. In the full analysis sample (FAS), 497(DYD [106 Russian]) and 477 (MVP [103 Russian]) subjects were randomized. DYD was non-inferior to MVP (FAS): difference in pregnancy rate at 12 weeks’ gestation of 4.7% in favor of DYD (95% CI: -1.2-10.6%). In Russian subjects, this difference was 14.2% in favor of DYD (95% CI: 1.1-27.2%). DYD and MVP had similar safety profiles. No health issues reported for Russian infants (6-month follow-up). Conclusion. In Russian subjects and overall, DYD was as efficacious as MVP. DYD may replace MVP for luteal support in IVF.

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About the authors

Gennady T. Sukhikh

Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

MD, PhD, Academician of Russian Academy of Sciences, Professor, Director

Igor I. Baranov

Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: i_baranov@oparina4.ru
MD, PhD, Professor, Head of the Organizing-Methodology Department

Galina A. Melnichenko

Endocrinology Research Centre

Email: Teofrast2000@mail.ru
MD, PhD, Professor, Academician of RAS; Deputy Directo

Nadezhda V. Bashmakova

Ural Research Institute of Maternal and Infant Care, Ministry of Health of Russia

Email: dr@nilomm.ru
MD, PhD, Professor; Director

Christophe Blockeel

University Hospitals Brussels

Email: christophe.blockeel@uzbrussel.be
MD, PhD, Professor, Medical Director of the Centre for Reproductive Medicine

Georg Griesinger

Email: griesing@uni-luebeck.de
MD, PhD, M.Sc, Professor; Head of Department of Gynecological Endocrinology and Reproductive Medicine & Head of Universitaeres Kinderwunschzentrum

Anna A. Lomakina

Abbott Laboratories LLC

Email: anna.lomakina@abbott.com
Senior Medical Advisor

Claire Pexman-Fieth

Abbott GmbH & Co. KG

Email: Claire.Pexman-Fieth@abbott.com
MD FRCSC, Senior Global Medical Director, Women’s Health, Clinical Development & Medical Affairs

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