Developing a core outcome set for future infertility research: an international consensus development study
Authors: Duffy J M N , AlAhwany H , Bhattacharya S , Collura B , Curtis C , Evers J L H , Farquharson R G , Franik S , Giudice L C , Khalaf Y , Knijnenburg J M L , Leeners B , Legro R S , Lensen S , Vazquez-Niebla J C , Mavrelos D , Mol B W J , Niederberger C , Ng E H Y , Otter A S , Puscasiu L , Rautakallio-Hokkanen S , Repping S , Sarris I , Simpson J L , Strandell A , Strawbridge C , Torrance H L , Vail A , van Wely M , Vercoe M A , Vuong N L , Wang A Y , Wang R , Wilkinson J , Youssef M A , Farquhar C M ,   Core Outcome Measure for Infertility Trials (COMMIT) initiative, Abou-Setta Ahmed M , Aguilera Juan J , Atanda Oluseyi O A , Balkenende Eva M E , Barnhart Kurt T , Beebeejaun Yusuf , Bhattacharya Sohinee , Black Megan , Bofill Magdalena , Chambers Georgina M , Chughtai Abrar A , Crosby Javier A , Cuevas-Sáiz Irene , D'Angel Arianna , Dubois Danielle D , Duckitt Kirsten , Encinas Carlos , Fincham Anita , Gerval Marie-Odile , Giang Nhu H , Gibreel Ahmed , Gingel Lynda J , Glanville Elizabeth J , Glujovsky Demian , Granne Ingrid , Griesinger Georg , Gupta Devashana , Hamzehgardeshi Zeinab , Hickey Martha , Hirsch Martin , Horton Marcos , Louise Hull M , Jain Shikha , Perez Marta Jansa , Jones Claire A , Jordan Vanessa , Kamath Mohan S , Kostova Elena , La Marca Antonio , Le Tien Khac , Leader Arthur , Li Jian , Loto Olabisi M , Marks Karen L , McTavish Alison R , Mills David J , Nair Raju R , Phuong Nguyen Dung Thi , Pacey Allan A , Sadler Lynn C , Sagle Peggy , Schwarze Juan-Enrique , Shapiro Heather M , Showell Marian , Siristatidis Charalampos S , Sood Akanksha , Tu Cam , Votteler Emma L , Wang Chi Chiu , Watson Andrew , Yossry Menem 
Published: September 2020

Abstract

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 (RCTs) 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, Fertility 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. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. 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. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. 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.