The microbiome in reproductive health: protocol for a systems biology approach using a prospective, observational study design.

Autor:	Krog MC; The Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.; Department of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark.; Department of Clinical Medicine, Copenhagen University, Copenhagen N, Denmark., Madsen ME; The Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.; Department of Gynecology, The Endometriosis Unit, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark., Bliddal S; The Department of Medical Endocrinology and Metabolism, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark.; Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark., Bashir Z; The Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.; Department of Obstetrics and Gynecology, Slagelse Hospital, Slagelse, Denmark., Vexø LE; The Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.; Department of Gynecology, The Endometriosis Unit, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark., Hartwell D; Department of Gynecology, The Endometriosis Unit, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark., Hugerth LW; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Fransson E; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Hamsten M; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Boulund F; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Wannerberger K; Ferring International Center SA, Saint-Prex, Switzerland., Engstrand L; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Schuppe-Koistinen I; Centre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden., Nielsen HS; The Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.; Department of Clinical Medicine, Copenhagen University, Copenhagen N, Denmark.; Department of Obstetrics and Gynecology, Copenhagen University Hospital, Hvidovre, Denmark.
Jazyk:	angličtina
Zdroj:	Human reproduction open [Hum Reprod Open] 2022 Mar 23; Vol. 2022 (2), pp. hoac015. Date of Electronic Publication: 2022 Mar 23 (Print Publication: 2022).
DOI:	10.1093/hropen/hoac015
Abstrakt:	Study Question: What is the microbiome profile across different body sites in relation to the normal menstrual cycle (with and without hormonal contraception), recurrent pregnancy loss (RPL) (before and during pregnancy, pregnancy loss or birth) and endometriosis (before, during and after surgery)? How do these profiles interact with genetics, environmental exposures, immunological and endocrine biomarkers? What Is Known Already: The microbiome is a key factor influencing human health and disease in areas as diverse as immune functioning, gastrointestinal disease and mental and metabolic disorders. There is mounting evidence to suggest that the reproductive microbiome may be influential in general and reproductive health, fertility and pregnancy outcomes. Study Design Size Duration: This is a prospective, longitudinal, observational study using a systems biology approach in three cohorts totalling 920 participants. Since microbiome profiles by shot-gun sequencing have never been investigated in healthy controls during varying phases of the menstrual cycle, patients with RPL and patients with endometriosis, no formal sample size calculation can be performed. The study period is from 2017 to 2024 and allows for longitudinal profiling of study participants to enable deeper understanding of the role of the microbiome and of host-microbe interactions in reproductive health. Participants/materials Setting Methods: Participants in each cohort are as follows: Part 1 MiMens-150 healthy women with or without hormonal contraception; Part 2 MiRPL-200 couples with RPL, 50 healthy couples with prior uncomplicated pregnancy and 150 newborns; Part 3 MiEndo-120 patients with endometriosis requiring surgery with or without hormonal treatment. Microbiome profiles from saliva, faeces, rectal mucosa, vaginal fluid and endometrium will be studied, as well as the Omics profile, endocrine disrupting chemicals and endocrine and immune factors in blood, hair, saliva and urine. Pregnancy loss products, seminal microbiome, HLA types, endometriotic tissue and genetic risk and comprehensive questionnaire data will also be studied, where appropriate. Correlations with mental and physical health will be evaluated. Study Funding/competing Interests: This work is supported by funding from Ferring Pharmaceuticals ([#MiHSN01] to H.S.N., M.C.K., M.E.M., L.E.V., L.E., I.S.-K., F.B., L.W.H., E.F. and M.H.), Rigshospitalet's Research Funds ([#E-22614-01 and #E-22614-02] to M.C.K. and [#E-22222-06] to S.B.), Niels and Desiree Yde's Foundation (S.B., endocrine analyses [#2015-2784]), the Musikforlæggerne Agnes and Knut Mørk's Foundation (S.B., endocrine and immune analyses [#35108-001]) and Oda and Hans Svenningsen's Foundation ([#F-22614-08] to H.S.N.). Medical writing assistance with this manuscript was provided by Caroline Loat, PhD, and funded by Ferring Pharmaceuticals. H.S.N. reports personal fees from Ferring Pharmaceuticals, Merck Denmark A/S, Ibsa Nordic, Astra Zeneca and Cook Medical outside the submitted work. K.W. is a full-time employee of Ferring Pharmaceuticals. No other conflicts are reported. Trial Registration Number: N/A. Trial Registration Date: N/A. Date of First Patient’s Enrolment: N/A. (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)
Databáze:	MEDLINE
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