TY - JOUR
T1 - The ReceptIVFity cohort study protocol to validate the urogenital microbiome as predictor for IVF or IVF/ICSI outcome
AU - Koedooder, Rivka
AU - Singer, Martin
AU - Schoenmakers, Sam
AU - Savelkoul, Paul Hendrik Maria
AU - Morré, Servaas Antonie
AU - De Jonge, Jonathan Dennis
AU - Poort, Linda
AU - Cuypers, Willem Jan Simon Stephanus
AU - Budding, Andries Edward
AU - Laven, Joop Stephanus Elisabeth
AU - Fleischer, K.
AU - Cohlen, B. J.
AU - Lambalk, C. B.
AU - Smeenk, J. M.J.S.
AU - Beckers, N. G.M.
AU - Broekmans, F. J.M.
AU - Den Hartog, J. E.
PY - 2018/12/7
Y1 - 2018/12/7
N2 - 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.
AB - 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.
KW - Adult
KW - Algorithms
KW - Bacteria/isolation & purification
KW - Cohort Studies
KW - Female
KW - Fertilization in Vitro
KW - Humans
KW - Infertility, Female/microbiology
KW - Microbiota/physiology
KW - Pregnancy
KW - Pregnancy Rate
KW - Prognosis
KW - Reproducibility of Results
KW - Research Design
KW - Sperm Injections, Intracytoplasmic
KW - Urine/microbiology
KW - Urogenital System/microbiology
KW - Vagina/microbiology
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85058125713&partnerID=8YFLogxK
U2 - 10.1186/s12978-018-0653-x
DO - 10.1186/s12978-018-0653-x
M3 - Article
C2 - 30526664
AN - SCOPUS:85058125713
SN - 1742-4755
VL - 15
SP - 202
JO - Reproductive health
JF - Reproductive health
IS - 1
M1 - 202
ER -