Rosielle, K.
Kamphuis, D.
van Welie, N.
Roest, I.
Mozes, A.
van Santbrink, E. J. P.
van de Laar, T.
Hooker, A. B.
Huppelschoten, A. G.
Li, W.
Bongers, M. Y.
Stoker, J.
van Wely, M.
Koks, C.
Lambalk, C. B.
Hemingway, A.
Mol, B. W. J.
Dreyer, K.
Mijatovic, V.
Funding for this research was provided by:
ZonMw (848082003)
Article History
Received: 28 March 2022
Accepted: 7 April 2022
First Online: 18 April 2022
Declarations
:
: This study is approved by the IRB of the Amsterdam UMC Vrije Universiteit (no. 2018.289) and the Dutch National Central Committee on Research involving Human Subjects (CCMO – NL66079.029.18), as well as by the Research Ethics Committee London Harrow (no. 20/LO/0607) and the boards of all participating hospitals. Protocol amendments will be communicated to participating hospitals after approval by the central IRB of Amsterdam UMC Vrije Universiteit. The study is registered as the H2Oil2 study in the Dutch Trial Register (no. NL7925, ExternalRef removed). Eligible women will receive oral and written information on the study, and after counselling by GCP-certified personnel women will be asked to sign informed consent prior to inclusion in this trial, in accordance with the ICH-GCP guidelines and local and national regulations.
: Not applicable as no participant data is presented in this manuscript.
: KR, DK, NvW, IR, AM, EvS, TvdL, AGH, MB, ABH, MvW have nothing to declare. WL reports receiving research grants from the NHMRC Centre for Research Excellence in Women’s Health in Reproductive Life and Norman Beischer Medical Research Foundation not related to this study. JS has a research agreement with Takeda not related to this topic. CK was a consultant for Conceptus Inc. CBL reports receiving research grants from Merck, Ferring and Guerbet. AH reports receiving travel and speakers fees from Guerbet. BM is supported by a National Health and Medical Research Council (NHMRC) Practitioner Fellowship (GNT1082548) and BM reports consultancy for ObsEva, Merck, Merck KGaA, iGenomix and Guerbet. KD reports receiving travel and speaker's fees from Guerbet and research grants from Guerbet. VM reports receiving travel and speaker's fees from Guerbet as well as research grants from Guerbet, Merck and Ferring.