Knowles, T.G.
García-Velasco, J.A.
Toribio, M.
Garrido, N.
Barrio Pedraza, A.I.
Colomé Rakosnik, C.
Salazar Vera, A.
Milnes, R.
Funding for this research was provided by:
viO HealthTech Limited
Article History
Received: 21 August 2024
Accepted: 8 December 2024
First Online: 3 February 2025
Declarations
:
: The research protocol makes the following declaration: This Research Project respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Convention on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, as well as the requirements of Spanish law in the field of biomedical research, as required by Organic Law 3/2018, of December 5, on Protection of Personal Data and guarantee of digital rights and bioethics and the Good Standards of Clinical Practice. The research protocol conforms to ISO 14155:2020. CEIM – HOSPITAL UNIVERSITY AND POLYTECHNIC LA FE, VALENCIA Ethics Committee issued a FAVORABLE REPORT on the Research Project in its session dated 19/07/2023: Title: “Continuous overnight monitoring of body temperature during IVF cycles as a proxy for establishing progesterone fluctuations. Signed in Valencia, on 19/07/2023 by JOSÉ MARÍA CANELLES GAMIR. Head of the technical secretariat of the CEIM. A copy of the ethics committee approval is available on request. The Ethics Committee reviewed a priori presented Clinical Investigation Protocol.” Registration number: 2023-692-1, Protocol code/acronym: 2211-VIO-164-JG. Sponsor: VIO HEALTHTECH LIMITED, Protocol Version 1.2 – Version date 30th May 2023, Information and Informed Consent Sheet Version 1.0. Version date 05-30-2023.
: Not applicable.
: Knowles T. is a shareholder of the study sponsor, viO HealthTech Limited. Milnes R. is a director, employee, share and option holder of the study sponsor, viO HealthTech Limited. There are no similar financial associations involving spouses or children under 18 years of age. The remaining authors have no competing interests to declare. There are no non-financial associations relevant to the submitted manuscript.