Individual participant data meta-analysis of trials comparing frozen versus fresh embryo transfer strategy (INFORM): a protocol
Lan N Vuong,
Rui Wang,
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
Affiliations
Lan N Vuong
Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
Rui Wang
associate professor
Rong Li
National Clinical Research Center for Obstetrics and Gynecology, Beijing, 100191, China
Karin Hammarberg
Kate Brian
Yun Sun
Shanghai Key laboratory for Assisted Reproduction and Reproductive Genetics, Center for Reproductive Medicine, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Pollyanna Hardy
9 Policy Research Unit in Maternal Health & Care, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, UK
Anja Pinborg
Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Siladitya Bhattacharya
professor
Sacha Stormlund
Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
David J McLernon
senior research fellow
Zi-Jiang Chen
Centre for Reproductive Medicine, Shandong University, Jinan, Shandong, China
Richard S Legro
Department of Obstetrics and Gynaecology, Penn State College of Medicine, Hershey, Pennsylvania, USA
Carlos Simon
Igenomix Foundation, INCLIVA Health Research Institute, Valencia, Spain
Shimona Lai
Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia
Marian G Showell
Obstetrics and Gynaecology, University of Aukland, Auckland, New Zealand
Daimin Wei
Centre for Reproductive Medicine, Shandong University, Jinan, Shandong, China
Ze Wang
SHANXI UNIVERSITY OF CHINESE MEDICINE, Basic Laboratory of Integrated Traditional Chinese and Western Medicine, Shan Xi, China
Keliang Wu
Centre for Reproductive Medicine, Shandong University, Jinan, Shandong, China
Xavier Santamaría
Igenomix Foundation, INCLIVA Health Research Institute, Valencia, Spain
Christophe Blockeel
Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium
Femke Mol
Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Anna P Ferraretti
Reproductive Medicine Unit, SISMeR, Bologna, Emilia-Romagna, Italy
Bruce S Shapiro
Department of Obstetrics and Gynecology, Kirk Kerkorian School of Medicine, Las Vegas, NV, USA
Forest C Garner
Department of Obstetrics and Gynecology, Kirk Kerkorian School of Medicine, Las Vegas, NV, USA
Christos A Venetis
Centre for Big Data Research in Health & School of Women`s and Children`s Health, University of New South Wales, Sydney, NSW, Australia
Abha Maheshwari
Aberdeen Centre of Reproductive Medicine, NHS Grampian, Aberdeen, UK
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.
