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Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials

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  • Jakob Doblinger
  • Barbara Cometti
  • Silvia Trevisan
  • Georg Griesinger

Abstract

Objective: To summarize efficacy and safety data on a new progesterone compound which is available for subcutaneous administration as compared to vaginally administered progesterone for luteal phase support in patients undergoing IVF treatment. Design: Data from two randomized phase III trials (07EU/Prg06 and 07USA/Prg05) performed according to GCP standards with a total sample size of 1435 per-protocol patients were meta-analyzed on an individual patient data level. Setting: University affiliated reproductive medicine unit. Patients: Subcutaneous progesterone was administered to a total of 714 subjects and vaginal progesterone was administered to a total of 721 subjects who underwent fresh embryo transfer after ovarian stimulation followed by IVF or ICSI. The subjects were between 18 and 42 years old and had a BMI

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  • Jakob Doblinger & Barbara Cometti & Silvia Trevisan & Georg Griesinger, 2016. "Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials," PLOS ONE, Public Library of Science, vol. 11(3), pages 1-12, March.
    • Handle: RePEc:plo:pone00:0151388
    DOI: 10.1371/journal.pone.0151388
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    Cited by:

    1. Georg Griesinger & Christophe Blockeel & Elke Kahler & Claire Pexman-Fieth & Jan I Olofsson & Stefan Driessen & Herman Tournaye, 2020. "Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis," PLOS ONE, Public Library of Science, vol. 15(11), pages 1-21, November.

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