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Article History

Received: 1 February 2021

Accepted: 1 November 2021

First Online: 4 January 2022

Declarations

:

: Ethical approval was given by the corresponding local Ethics Committees to the protocol with reference IGX1-MIC-CS-17-05 as follows: Western Institutional Review Board (IVF-Florida, USA, study code 1176556, July 17, 2017; RMA Connecticut, USA, study code 1177331, July 31, 2017; Dominion Fertility, USA, study code 1176555, July 22, 2017; Missouri Center for Reproductive Medicine, USA, study code 1179405, October 10, 2017; Pacific Centre for Reproductive Medicine, Canada, study code 1179667, December 13, 2017); Comite de Etica de la Investigación con Medicamentos del Hospital Universitario de la Princesa (ProcreaTec, Spain, register number 3133, July 13, 2017); Comite de Etica de la Investigacion Costa del Sol (Clinica Fertia, Spain, code 006_jun17_PI-ERA-Microbioma, June 29, 2017); Comite de Bioetica del Instituto de Investigaciones Clinicas Rosario (Gestanza Medicina Reproductiva, Argentina, March 27, 2018); Comite de Etica en Investigación Centro de Educacion Medica e Investigaciones Clinicas “Norberto Quirno” (Pregna Medicina Reproductiva, Argentina, October 13, 2017); Human Medical Research Ethics Committee (HMREC) for Private Healthcare and Research Centres Malaysia (Alpha IVF & Women’s Specialists Centre, Malaysia, October 3, 2017); Oak Clinic Group’s Ethics Committee (Oak Clinic Sumiyoshi, Japan, May 29, 2017); Comite de Etica en Investigación New Hope Fertility Center (New Hope Fertility Center, Mexico, Register number RA-2017-04, June 9, 2017); Uskudar Universitesi Girisimsel Olamayan Arastirmalar Etik Kurulum (Bahceci Group, Turkey, January 25, 2018). All participants provided written informed consent. Data were monitored by clinical research associates through on-site and/or remote visits, and the database was properly curated by the data manager. All queries were duly solved and closed.

: Not applicable.

: IM, DPV, MGM, DB, CG, DV and CS are partially employed by Igenomix R&D. The rest of the authors declare that they have no competing interests.