Evidence map›Paper›PMID 35441092›Full record

ReviewHuman reproduction open2022

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

Maria Christine Krog, Mette Elkjær Madsen, Sofie Bliddal, Zahra Bashir, Laura Emilie Vexø, Dorthe Hartwell, Luisa W Hugerth, Emma Fransson, Marica Hamsten, Fredrik Boulund and 4 more

Abstract readReview
In one paragraph

Review in Human reproduction open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Maria Christine KrogThe Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-2110-0479
Mette Elkjær MadsenThe Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-7767-9849
Sofie BliddalThe Department of Medical Endocrinology and Metabolism, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark.ORCID https://orcid.org/0000-0002-2456-1019
Zahra BashirThe Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-2497-282X
Laura Emilie VexøThe Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.
Dorthe HartwellDepartment of Gynecology, The Endometriosis Unit, Rigshospitalet, Copenhagen University Hospital, Copenhagen Ø, Denmark.
Luisa W HugerthCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-5432-1764
Emma FranssonCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-9010-8522
Marica HamstenCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
Fredrik BoulundCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-3806-323X
Kristin WannerbergerFerring International Center SA, Saint-Prex, Switzerland.
Lars EngstrandCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-7713-2373
Ina Schuppe-KoistinenCentre for Translational Microbiome Research (CTMR), Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-1423-3089
Henriette Svarre NielsenThe Recurrent Pregnancy Loss Unit, The Capital Region, The Fertility Clinic, Copenhagen University Hospitals Rigshospitalet and Hvidovre, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-2106-8103

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

study questionWhat 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

methodsParticipants 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.

Indexed as

contraceptionendocrinologyendometriosisfertilityimmunologymenstrual cyclemicrobiomepregnancy lossrecurrent pregnancy loss

Identifiers

PMID35441092
PMCPMC9014536

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.