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

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...

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Main Authors: Lan N Vuong, Rui Wang, Ben W Mol, Rong Li, Karin Hammarberg, Kate Brian, Yun Sun, Pollyanna Hardy, Anja Pinborg, Siladitya Bhattacharya, Sacha Stormlund, David J McLernon, Zi-Jiang Chen, Richard S Legro, Carlos Simon, Shimona Lai, Marian G Showell, Daimin Wei, Ze Wang, Keliang Wu, Xavier Santamaría, Christophe Blockeel, Femke Mol, Anna P Ferraretti, Bruce S Shapiro, Forest C Garner, Christos A Venetis, Abha Maheshwari, Gwenda Burns
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e062578.full
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author Lan N Vuong
Rui Wang
Ben W Mol
Rong Li
Karin Hammarberg
Kate Brian
Yun Sun
Pollyanna Hardy
Anja Pinborg
Siladitya Bhattacharya
Sacha Stormlund
David J McLernon
Zi-Jiang Chen
Richard S Legro
Carlos Simon
Shimona Lai
Marian G Showell
Daimin Wei
Ze Wang
Keliang Wu
Xavier Santamaría
Christophe Blockeel
Femke Mol
Anna P Ferraretti
Bruce S Shapiro
Forest C Garner
Christos A Venetis
Abha Maheshwari
Gwenda Burns
author_facet Lan N Vuong
Rui Wang
Ben W Mol
Rong Li
Karin Hammarberg
Kate Brian
Yun Sun
Pollyanna Hardy
Anja Pinborg
Siladitya Bhattacharya
Sacha Stormlund
David J McLernon
Zi-Jiang Chen
Richard S Legro
Carlos Simon
Shimona Lai
Marian G Showell
Daimin Wei
Ze Wang
Keliang Wu
Xavier Santamaría
Christophe Blockeel
Femke Mol
Anna P Ferraretti
Bruce S Shapiro
Forest C Garner
Christos A Venetis
Abha Maheshwari
Gwenda Burns
collection DOAJ
description 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.
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spelling doaj-art-1899634ebdef4d409bae8cfd81542a7c2025-01-30T20:15:15ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-062578Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol Lan N Vuong0Rui Wang1Ben W Mol2Rong Li3Karin Hammarberg4Kate BrianYun Sun5Pollyanna Hardy6Anja Pinborg7Siladitya Bhattacharya8Sacha Stormlund9David J McLernon10Zi-Jiang Chen11Richard S Legro12Carlos Simon13Shimona Lai14Marian G Showell15Daimin Wei16Ze Wang17Keliang Wu18Xavier Santamaría19Christophe Blockeel20Femke Mol21Anna P Ferraretti22Bruce S Shapiro23Forest C Garner24Christos A Venetis25Abha Maheshwari26Gwenda BurnsDepartment of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, VietnamDepartment of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia4 Obstetrics and Gynecology, Monash Medical School, Clayton, Victoria, AustraliaNational Clinical Research Center for Obstetrics and Gynecology, Beijing, 100191, ChinaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, AustraliaShanghai Key laboratory for Assisted Reproduction and Reproductive Genetics, Center for Reproductive Medicine, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, ChinaNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UKFertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark3 School of Medicine Medical Sciences & Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB24 3FX, UKFertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmarksenior research fellowCentre for Reproductive Medicine, Shandong University, Jinan, Shandong, ChinaDepartment of Obstetrics and Gynecology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USAIgenomix Foundation, INCLIVA Health Research Institute, Valencia, SpainDepartment of Obstetrics and Gynaecology, Monash University, Clayton, VIC, AustraliaObstetrics and Gynaecology, University of Aukland, Auckland, New ZealandCentre for Reproductive Medicine, Shandong University, Jinan, Shandong, ChinaCentre for Reproductive Medicine, Shandong University, Jinan, Shandong, ChinaCentre for Reproductive Medicine, Shandong University, Jinan, Shandong, ChinaIgenomix Foundation, INCLIVA Health Research Institute, Valencia, SpainCentre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, BelgiumCentre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsReproductive Medicine Unit, SISMeR, Bologna, Emilia-Romagna, ItalyDepartment of Obstetrics and Gynecology, Kirk Kerkorian School of Medicine, Las Vegas, NV, USADepartment of Obstetrics and Gynecology, Kirk Kerkorian School of Medicine, Las Vegas, NV, USACentre for Big Data Research in Health & School of Women`s and Children`s Health, University of New South Wales, Sydney, NSW, AustraliaAberdeen Centre of Reproductive Medicine, NHS Grampian, Aberdeen, UKIntroduction 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.https://bmjopen.bmj.com/content/12/7/e062578.full
spellingShingle Lan N Vuong
Rui Wang
Ben W Mol
Rong Li
Karin Hammarberg
Kate Brian
Yun Sun
Pollyanna Hardy
Anja Pinborg
Siladitya Bhattacharya
Sacha Stormlund
David J McLernon
Zi-Jiang Chen
Richard S Legro
Carlos Simon
Shimona Lai
Marian G Showell
Daimin Wei
Ze Wang
Keliang Wu
Xavier Santamaría
Christophe Blockeel
Femke Mol
Anna P Ferraretti
Bruce S Shapiro
Forest C Garner
Christos A Venetis
Abha Maheshwari
Gwenda Burns
Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
BMJ Open
title Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
title_full Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
title_fullStr Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
title_full_unstemmed Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
title_short Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
title_sort individual participant data meta analysis of trials comparing frozen versus fresh embryo transfer strategy inform a protocol
url https://bmjopen.bmj.com/content/12/7/e062578.full
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