Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study

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Transcripción de la presentación:

Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Gillian Lockwood, M.D., Georg Griesinger, M.D., Barbara Cometti, Ph.D. Giuseppe de Placido, Carlo Alviggi, Antonio Ranieri, Ida Strina Enrico Papaleo, Michela Molgora Andrea R. Genazzani, Paolo Artini, Vito Cela, Nicola Pluchino Annibale Volpe, Antonio la Marca, Giovanna Sighinolgi Klaus Diedrich Luca Gianaroli, Christina Grugnetti Christian de Geyter Janos Urbancsek Abey Eapen Guido Ragni Yacoub Khalaf Luca Sabatini Bruno Engl Fertility and Sterility Volume 101, Issue 1, Pages 112-119.e3 (January 2014) DOI: 10.1016/j.fertnstert.2013.09.010 Copyright © 2014 American Society for Reproductive Medicine Terms and Conditions

Figure 1 Participant flow through the trial. ITT = intention to treat; PP = per protocol. aScreening failures because inclusion/exclusion criteria not met (n = 36): <3 oocytes retrieved (n = 24); basal 17β-E2 level and/or normal uterine cavity (n = 11); >3 previous ART treatments (n = 1); cycle interrupted due to poor response (n = 8); cycle interrupted due to ovarian hyperstimulation syndrome (OHSS) risk (n = 5); voluntary withdrawal (n = 3); only atretic oocytes collected (n = 2); adverse event (n = 1); violation of the protocol (need of a concurrent medication prohibited by the protocol [n = 1]); embryo transfer (ET) not performed (endometrial thickness <4 mm [n = 1]). bET not performed for following reasons: Prolutex: failed fertilization (n = 6); risk of OHSS (n = 3); OHSS (n = 1); no progressing embryos (n = 6). Crinone: failed fertilization (n = 8); risk of OHSS (n = 2); no progressing embryos (n = 3). cProtocol violators: Prolutex, intake of not allowed medication progynova-E2 for luteal support (n = 2), intake of not allowed medication dexamethasone (n = 1); crinone, intake of not allowed medication progynova-E2 (n = 5), intake of not allowed medication dexamethasone (n = 5). Fertility and Sterility 2014 101, 112-119.e3DOI: (10.1016/j.fertnstert.2013.09.010) Copyright © 2014 American Society for Reproductive Medicine Terms and Conditions