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Reprod Health. 2018 Dec 7;15(1):202. doi: 10.1186/s12978-018-0653-x.

The ReceptIVFity cohort study protocol to validate the urogenital microbiome as predictor for IVF or IVF/ICSI outcome.

Author information

1
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus University Medical Centre, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands. r.koedooder@erasmusmc.nl.
2
Laboratory of Immunogenetics, Department of Medical Microbiology and Infection Control, VU University Medical Centre, De Boelelaan 1108, 1081 HZ, Amsterdam, the Netherlands.
3
Division Obstetrics, Department of Obstetrics and Gynaecology, Erasmus University Medical Centre, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
4
Department of Medical Microbiology, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
5
Institute of Public Health Genomics, Department of Genetics and Cell Biology, Research Institute GROW, Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, The Netherlands.
6
ARTPred B.V., Kruisweg 647, 2131 NC, Hoofddorp, The Netherlands.
7
IS-Diagnostics Ltd, spin-off at Department of Medical Microbiology and Infection Control, VU University Medical Centre, de Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
8
Dutch Division, MVZ VivaNeo Kinderwunschzentrum Düsseldorf GmbH, Völklinger Straße 4, 40219, Düsseldorf, Germany.
9
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus University Medical Centre, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.

Abstract

BACKGROUND:

During the last decade, research has shown that besides the known predictive factors, such as duration of subfertility, a women's age, the body mass index, also the microbiome might affect fertility. Micro-organisms together with their genetic information and the milieu in which they interact are called the microbiome. Studies have shown that the presence of certain microbiota during assisted reproductive technology (ART) has a positive impact on the outcome. However, the potential role of using the microbiome as a predictor for outcome of ART has not yet been investigated.

METHODS:

In a prospective study, 300 women of reproductive age and with an indication for in-vitro Fertilization (IVF) with or without Intra Cytoplasmic Sperm Injection (ICSI) treatment will be included. Prior to the IVF or IVF-ICSI treatment, these women provided a midstream urine sample and a vaginal swab. The composition of the urinary and vaginal microbiome will be analysed with both Next Generation Sequencing and the IS-pro technique. The endpoints of the study are pregnancy achieved after fresh embryo transfer (ET) and within the subsequent year after inclusion. External validation of the findings will take place in an additional cohort of 50 women with an IVF or IVF-ICSI indication.

DISCUSSION:

In the proposed study, the predictive accuracy of the composition of the urinary and vaginal microbiome for IVF or IVF-ICSI outcome will be only validated for fresh ET. Follow-up has to show whether the predictive accuracy will be similar during the consecutive frozen ET's as part of the IVF or IVF-ICSI treatment or for subsequent stimulated or natural cycles. In addition, external validation will take place in another cohort and hospital. Predictive knowledge of the microbiome profile may enable couples to make a more substantiated decision on whether to continue treatment or not. Hence, the unnecessary physical and emotional burden of a failed IVF or IVF-ICSI treatment can be avoided.

TRIAL REGISTRATION:

ISRCTN ISRCTN83157250 . Registered 17 August 2018. Retrospectively registered.

KEYWORDS:

Implantation; Microbiota; Prediction; Urinary; Vaginal

PMID:
30526664
PMCID:
PMC6286554
DOI:
10.1186/s12978-018-0653-x
[Indexed for MEDLINE]
Free PMC Article

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