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

Gennady T. Sukhikh; Igor I. Baranov; Galina A. Melnichenko; Nadezhda V. Bashmakova; Christophe Blockeel; Georg Griesinger; Anna A. Lomakina; Claire Pexman-Fieth

doi:10.18565/aig.2017.7.75-95

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

Gennady T. Sukhikh, Igor I. Baranov, Galina A. Melnichenko, Nadezhda V. Bashmakova, Christophe Blockeel, Georg Griesinger, Anna A. Lomakina, Claire Pexman-Fieth

Klinik für Frauenheilkunde und Geburtshilfe

6 Zitate (Scopus)

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.

Originalsprache	Englisch
Zeitschrift	Akusherstvo i Ginekologiya (Russian Federation)
Ausgabenummer	7
Seiten (von - bis)	75-95
Seitenumfang	21
ISSN	0300-9092
DOIs	https://doi.org/10.18565/aig.2017.7.75-95
Publikationsstatus	Veröffentlicht - 2017

Fördermittel

Abbott study support: Elke Kahler, Erik van Leeuwen and Vladimir Kovalev. Manuscript support: Victoria Harvey-Jones (Alpharmaxim Healthcare Communications). We would like to thank the following study investigators from their respective countries. Austria: Katharina Walch (Vienna); Belgium: Dirk Coeman (Brasschaat), Tom Coetsier (Gent), Wim Decleer (Gent), Caroline Lecocq (Brussels), Willem Ombelet (Genk), Karen Peeraer (Leuven), Jean-François Simon (Mons), and Christine Wyns (Brussels); Finland: Kirsimarja Kestilä (Turku), Anna Kivijärvi (Jyväskylä), and Niklas Simberg (Helsinki); Germany: Maren Goeckenjan-Festag (Dresden), Anette Siemann (Berlin), Thomas Strowitzki (Heidelberg), and Peter Sydow (Berlin); Israel: Ilan Calderon (Haifa), Adrian Ellenbogen (Hadera), Eitan Lunenfeld (Beer Sheva), Daniel Seidman (Tel Aviv), and Alex Simon (Jerusalem); Russia: Irina Dankova (Ekaterinburg), Tatiana Gurskaya (Moscow), Vladimir Kuzmin (Moscow), Irina Vitjaseva (Moscow) and Irina Barmina (Mocow), Vera Prilepskaya (Moscow), and Nina Tatarova (Saint Petersburg); Spain: Ernesto Bosch Aparicio (Valencia), Ana Belen Casas Balazote (Barcelona), Marcos Ferrando Serrano (Bilbao), Antonio Gosalvez (Pozuelo de Alarcón), and Roberto Matorras (Barakaldo). Funding This study was sponsored and supported by Abbott Established Pharmaceuticals. Conflict of interest G. Sukhikh has nothing to disclose; I. Baranov has nothing to disclose; G. Melnichenko has nothing to disclose; N. Bashmakova has nothing to disclose; C. Blockeel has received fees from Abbott, Ferring, Finox, Merck Serono, and MSD; G. Griesinger has received investigator fees from Abbott during the conduct of the study, outside of this submitted work has received personal fees and non-financial support from MSD, Ferring, Merck Serono, Finox, TEVA, Glycotope, as well as personal fees from Vitrolife, NMC Healthcare LLC, ReprodWissen LLC, and ZIVA LLC; A. Lomakina is an employee of Abbott Laboratories, Moscow, Russia; C. Pexman-Fieth is an employee of Abbott GmbH & Co. KG, Wiesbaden, Germany and owns shares of Abbott.

UN SDGs

Dieser Output leistet einen Beitrag zu folgendem(n) Ziel(en) für nachhaltige Entwicklung

SDG 3 – Gesundheit und Wohlergehen

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10.18565/aig.2017.7.75-95

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Sukhikh, G. T., Baranov, I. I., Melnichenko, G. A., Bashmakova, N. V., Blockeel, C., Griesinger, G., Lomakina, A. A., & Pexman-Fieth, C. (2017). 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. Akusherstvo i Ginekologiya (Russian Federation), (7), 75-95. https://doi.org/10.18565/aig.2017.7.75-95

@article{398cf218b94947888723631156c87f51,

title = "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",

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{\textquoteright} 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{\textquoteright} 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.",

author = "Sukhikh, \{Gennady T.\} and Baranov, \{Igor I.\} and Melnichenko, \{Galina A.\} and Bashmakova, \{Nadezhda V.\} and Christophe Blockeel and Georg Griesinger and Lomakina, \{Anna A.\} and Claire Pexman-Fieth",

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year = "2017",

doi = "10.18565/aig.2017.7.75-95",

language = "English",

pages = "75--95",

journal = "Akusherstvo i Ginekologiya (Russian Federation)",

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Sukhikh, GT, Baranov, II, Melnichenko, GA, Bashmakova, NV, Blockeel, C, Griesinger, G, Lomakina, AA & Pexman-Fieth, C 2017, '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', Akusherstvo i Ginekologiya (Russian Federation), Nr. 7, S. 75-95. https://doi.org/10.18565/aig.2017.7.75-95

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. / Sukhikh, Gennady T.; Baranov, Igor I.; Melnichenko, Galina A. et al.
in: Akusherstvo i Ginekologiya (Russian Federation), Nr. 7, 2017, S. 75-95.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - 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

AU - Sukhikh, Gennady T.

AU - Baranov, Igor I.

AU - Melnichenko, Galina A.

AU - Bashmakova, Nadezhda V.

AU - Blockeel, Christophe

AU - Griesinger, Georg

AU - Lomakina, Anna A.

AU - Pexman-Fieth, Claire

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85033549730

U2 - 10.18565/aig.2017.7.75-95

DO - 10.18565/aig.2017.7.75-95

M3 - Journal articles

AN - SCOPUS:85033549730

SN - 0300-9092

SP - 75

EP - 95

JO - Akusherstvo i Ginekologiya (Russian Federation)

JF - Akusherstvo i Ginekologiya (Russian Federation)

IS - 7

ER -

Sukhikh GT, Baranov II, Melnichenko GA, Bashmakova NV, Blockeel C, Griesinger G et al. 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. Akusherstvo i Ginekologiya (Russian Federation). 2017;(7):75-95. doi: 10.18565/aig.2017.7.75-95