Kamphuis, D.
Rosielle, K.
van Welie, N.
Roest, I.
van Dongen, A. J.C.M.
Brinkhuis, E. A.
Bourdrez, P.
Mozes, A.
Verhoeve, H. R.
van der Ham, D. P.
Vrouenraets, F. P.J.M.
Risseeuw, J. J.
van de Laar, T.
Janse, F.
den Hartog, J. E.
de Hundt, M.
Hooker, A. B.
Huppelschoten, A. G.
Pieterse, Q. D.
Bongers, M. Y.
Stoker, J.
Koks, C. A.M.
Lambalk, C. B.
Hemingway, A.
Li, W.
Mol, B. W.J.
Dreyer, K.
Mijatovic, V.
Article History
Received: 13 February 2023
Accepted: 21 April 2023
First Online: 6 May 2023
Change Date: 10 August 2023
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12905-023-02574-y
Declarations
:
: DK, NvW, IR, AJCMvD, EAB, PB, AM, HRV, DPvdH, FPJMV, JJR, TvdL, JEdH, MdH, AGH, QDP, MYB, and CAMK have nothing to declare. KR and FJ reports receiving a travel grant from Merck. ABH reports receiving a travel –and speaker’s fee from Merck and speakers fee from Nordic Pharma. JS has a research agreement with Takeda not related to this topic. CBL reports receiving research grants from Merck, Ferring and Guerbet. AH reports receiving travel and speaker’s fees from Guerbet and reports past consultancy for Guerbet. 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. BWM is supported by a NHMRC investigator grant (GNT1176437) and reports consultancy for ObsEva and Merck and travel support from Merck. 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.
: This study is carried out in accordance with the Declaration of Helsinki, the ICH-GCP guidelines and the local regulations. It is approved by the National Central Committee on Research involving Human Subjects (CCMO – NL 62838.029.18), by the Ethics committee of the Amsterdam UMC, location Vrije Universiteit Amsterdam (Ref. No. 2018.291, date 25th of July 2019) and by the boards of all participating hospitals. The study is also approved by the Research Ethics Committee London Harrow in the UK (Ref. No. 20/LO/0608, date 1st of July 2020).The study is registered in International Clinical Trials Registry Platform: EUCTR2018-004153-24-NL.Eligible women will counseled for the study by trained research staff and all women will receive written information. Those women who agree to participate will be asked to sign a written consent form. After informed consent, women will be randomly allocated to the intervention group or control group.
: Not applicable.