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Developing a core outcome set for future infertility research: an international consensus development study

Fertility and Sterility, volume 115, issue 1, page 191-200 – 2020-11-29

J. M. N. Duffy a,b; H. AlAhwany,c; S. Bhattacharya,d; B. Collura,e; C. Curtis,f,g; J. L. H. Evers,h; R. G. Farquharson,i; S. Franik,j; L. C. Giudice,k,l; Y. Khalaf,m J. M. L. Knijnenburg,n; B. Leeners,o; R. S. Legro,p S. Lensen,q; J. C. Vazquez-Niebla,r; D. Mavrelos,s; B. W. J. Mol,t; C. Niederberger,u; E. H. Y. Ng,v,w; A. S. Otter,x; L. Puscasiu,y; S. Rautakallio-Hokkanen,z; S. Repping,aa; I. Sarris,a; J. L. Simpson,bb; A. Strandell,cc; C. Strawbridge,dd; H. L. Torrance,ee; A. Vail,ff M. van Wely,aa; M. A. Vercoe,gg; N. L. Vuong,hh; A. Y. Wang,ii; R. Wang,t; J. Wilkinson,ff; M. A. Youssef,jj; C. M. Farquhargg and the Core Outcome Measure for Infertility Trials (COMMIT) initiative

Published: 29 November, 2020

a King’s Fertility, Fetal Medicine Research Institute, London, UK;
b Institute for Women’s Health, University College London, London, UK;
c School of Medicine, University of Nottingham, Derby, UK;
d School of Medicine, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, UK;
e RESOLVE: The National Infertility Association, Virginia, United States;
f Fertility New Zealand, Auckland, New Zealand;
g School of Psychology, University of Waikato, Hamilton, New Zealand;
h Maastricht University Medical Centre, Maastricht, The Netherlands;
i Department of Obstetrics and Gynaecology, Liverpool Women’s NHS Foundation Trust, Liverpool, UK;
j  Department of Obstetrics and Gynaecology, Munster University Hospital, Munster, Germany; 
k Center for Research, Innovation and Training in Reproduction and Infertility, Center for
Reproductive Sciences, University of California, San Francisco, California, Untied States;
l  International Federation of Fertility Societies, Philadelphia, Pennsylvania, United States;
m Department of Women and Children’s Health, King’s College London, Guy’s Hospital, London;
n Freya Dutch Infertility Association, Gorinchem, The Netherlands;
o Department of Reproductive Endocrinology, University Hospital Zurich, Zurich, Switzerland;
p Department of Obstetrics and Gynaecology, Penn State College of Medicine, Pennsylvania, USA;
q Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia;
r Cochrane Iberoamerica, Biomedical Research Institute Sant Pau, Barcelona, Spain;
s Reproductive Medicine Unit, University College Hospital, London, UK;
t Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia;
u Department of Urology, University of Illinois at Chicago College of Medicine, Chicago, Illinois, USA;
v Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong;
w Shenzhen Key Laboratory of Fertility Regulation, The University of Hong Kong-Shenzhen Hospital, China;
x Osakidetza OSI, Bilbao, Basurto, Spain;
y University of Medicine, Pharmacy, Sciences and Technology, Targu Mures, Romania;
z Fertility Europe, Evere, Belgium;
aa Center for Reproductive Medicine, Amsterdam Reproduction and Development Institute, Amsterdam University Medical Centres, Amsterdam, The Netherlands;
bb Department of Human and Molecular Genetics, Florida International University, Florida, Untied States;
cc Department of Obstetrics and Gynecology, Sahlgrenska Academy, University of Gothenburg,
Goteborg, Sweden;
dd Fertility Network UK, London, UK;
ee Department of Reproductive Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands;
ff Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK;
gg Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand;
hh Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy in Ho Chi Minh City, Ho Chi Minh City, Vietnam;
ii Faculty of Health, University of Technology, Sydney, Broadway, Australia;
jj Department of Obstetrics & Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt


Study Question: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed?
Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility.
What is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.
Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).
Participants/Materials, Setting, Methods: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.
Main Results and the Role of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable.
Limitations, Reasons for Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold.
Wider Implications of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set.
Study Funding/Competing Interest(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Jose Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form.
Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023. (Fertil Steril 2020;-:-–-. 2020 by American Society for Reproductive Medicine.)


Consensus development study, core outcome sets, modified Delphi method, modified Nominal Group Technique, outcome measures, outcomes