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Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol

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  • Rui Wang
  • David J McLernon
  • Shimona Lai
  • Marian G Showell
  • Zi-Jiang Chen
  • Daimin Wei
  • Richard S Legro
  • Ze Wang
  • Yun Sun
  • Keliang Wu
  • Lan N Vuong
  • Pollyanna Hardy
  • Anja Pinborg
  • Sacha Stormlund
  • Xavier Santamaría
  • Carlos Simón
  • Christophe Blockeel
  • Femke Mol
  • Anna P Ferraretti
  • Bruce S Shapiro
  • Forest C Garner
  • Rong Li
  • Christos A Venetis
  • Ben W Mol
  • Siladitya Bhattacharya
  • Abha Maheshwari
  • INFORM Collaboration
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INTRODUCTION: Existing randomised controlled trials (RCTs) comparing a freeze-all embryo transfer strategy and a fresh embryo transfer strategy have shown conflicting results. A freeze-all or a fresh transfer policy may be preferable for some couples undergoing in-vitro fertilisation (IVF), but it is unclear which couples would benefit most from each policy, how and under which protocols. Therefore, we plan a systematic review and individual participant data meta-analysis of RCTs comparing a freeze-all and a fresh transfer policy.

METHODS AND ANALYSIS: We will search electronic databases (Medline, Embase, PsycINFO and CENTRAL) and trial registries (ClinicalTrials.gov and the International Clinical Trials Registry Platform) from their inception to present to identify eligible RCTs. We will also check reference lists of relevant papers. The search was performed on 23 September 2020 and will be updated. We will include RCTs comparing a freeze-all embryo transfer strategy and a fresh embryo transfer strategy in couples undergoing IVF. The primary outcome will be live birth resulting from the first embryo transfer. All outcomes listed in the core outcome set for infertility research will be reported. We will invite the lead investigators of eligible trials to join the Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM) collaboration and share the deidentified individual participant data (IPD) of their trials. We will harmonise the IPD and perform a two-stage meta-analysis and examine treatment-covariate interactions for important baseline characteristics.

ETHICS AND DISSEMINATION: The study ethics have been granted by the Monash University Human Research Ethics Committee (Project ID: 30391). The findings will be disseminated via presentations at international conferences and publication in peer-reviewed journals.

PROSPERO REGISTRATION NUMBER: CRD42021296566.

Original languageEnglish
Article numbere062578
JournalBMJ Open
Volume12
Issue number7
Pages (from-to)e062578
ISSN2044-6055
DOIs
Publication statusPublished - 18 Jul 2022

Bibliographical note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

    Research areas

  • Embryo Transfer/methods, Female, Fertilization in Vitro/methods, Humans, Live Birth, Meta-Analysis as Topic, Pregnancy, Pregnancy Rate, Pregnancy, Multiple, Systematic Reviews as Topic, subfertility, perinatology, clinical trials, reproductive medicine, embryology

ID: 79690252