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Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)

BACKGROUND: Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called ‘scratching’, has been proposed to positively affect the chance of implantation after embryo transf...

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Autores principales: van Hoogenhuijze, N. E., Torrance, H. L., Mol, F., Laven, J. S. E., Scheenjes, E., Traas, M. A. F., Janssen, C., Cohlen, B., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R., Maas, J. W. M., Moll, E., Fleischer, K., van Hooff, M. H., de Koning, C., Cantineau, A., Lambalk, C. B., Verberg, M., Nijs, M., Manger, A. P., van Rumste, M., van der Voet, L. F., Preys-Bosman, A., Visser, J., Brinkhuis, E., den Hartog, J. E., Sluijmer, A., Jansen, F. W., Hermes, W., Bandell, M. L., Pelinck, M. J., van Disseldorp, J., van Wely, M., Smeenk, J., Pieterse, Q. D., Boxmeer, J.C., Groenewoud, E.R., Eijkemans, M. J. C., Kasius, J. C., Broekmans, F. J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521151/
https://www.ncbi.nlm.nih.gov/pubmed/28732531
http://dx.doi.org/10.1186/s12905-017-0378-y
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author van Hoogenhuijze, N. E.
Torrance, H. L.
Mol, F.
Laven, J. S. E.
Scheenjes, E.
Traas, M. A. F.
Janssen, C.
Cohlen, B.
Teklenburg, G.
de Bruin, J. P.
van Oppenraaij, R.
Maas, J. W. M.
Moll, E.
Fleischer, K.
van Hooff, M. H.
de Koning, C.
Cantineau, A.
Lambalk, C. B.
Verberg, M.
Nijs, M.
Manger, A. P.
van Rumste, M.
van der Voet, L. F.
Preys-Bosman, A.
Visser, J.
Brinkhuis, E.
den Hartog, J. E.
Sluijmer, A.
Jansen, F. W.
Hermes, W.
Bandell, M. L.
Pelinck, M. J.
van Disseldorp, J.
van Wely, M.
Smeenk, J.
Pieterse, Q. D.
Boxmeer, J.C.
Groenewoud, E.R.
Eijkemans, M. J. C.
Kasius, J. C.
Broekmans, F. J. M.
author_facet van Hoogenhuijze, N. E.
Torrance, H. L.
Mol, F.
Laven, J. S. E.
Scheenjes, E.
Traas, M. A. F.
Janssen, C.
Cohlen, B.
Teklenburg, G.
de Bruin, J. P.
van Oppenraaij, R.
Maas, J. W. M.
Moll, E.
Fleischer, K.
van Hooff, M. H.
de Koning, C.
Cantineau, A.
Lambalk, C. B.
Verberg, M.
Nijs, M.
Manger, A. P.
van Rumste, M.
van der Voet, L. F.
Preys-Bosman, A.
Visser, J.
Brinkhuis, E.
den Hartog, J. E.
Sluijmer, A.
Jansen, F. W.
Hermes, W.
Bandell, M. L.
Pelinck, M. J.
van Disseldorp, J.
van Wely, M.
Smeenk, J.
Pieterse, Q. D.
Boxmeer, J.C.
Groenewoud, E.R.
Eijkemans, M. J. C.
Kasius, J. C.
Broekmans, F. J. M.
author_sort van Hoogenhuijze, N. E.
collection PubMed
description BACKGROUND: Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called ‘scratching’, has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. METHOD: Multicenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2(nd) fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2(nd) IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure. DISCUSSION: Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle. TRIAL REGISTRATION: NTR 5342, registered July 31(st), 2015. PROTOCOL VERSION: Version 4.10, January 4th, 2017.
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spelling pubmed-55211512017-07-21 Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342) van Hoogenhuijze, N. E. Torrance, H. L. Mol, F. Laven, J. S. E. Scheenjes, E. Traas, M. A. F. Janssen, C. Cohlen, B. Teklenburg, G. de Bruin, J. P. van Oppenraaij, R. Maas, J. W. M. Moll, E. Fleischer, K. van Hooff, M. H. de Koning, C. Cantineau, A. Lambalk, C. B. Verberg, M. Nijs, M. Manger, A. P. van Rumste, M. van der Voet, L. F. Preys-Bosman, A. Visser, J. Brinkhuis, E. den Hartog, J. E. Sluijmer, A. Jansen, F. W. Hermes, W. Bandell, M. L. Pelinck, M. J. van Disseldorp, J. van Wely, M. Smeenk, J. Pieterse, Q. D. Boxmeer, J.C. Groenewoud, E.R. Eijkemans, M. J. C. Kasius, J. C. Broekmans, F. J. M. BMC Womens Health Study Protocol BACKGROUND: Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called ‘scratching’, has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. METHOD: Multicenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2(nd) fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2(nd) IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure. DISCUSSION: Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle. TRIAL REGISTRATION: NTR 5342, registered July 31(st), 2015. PROTOCOL VERSION: Version 4.10, January 4th, 2017. BioMed Central 2017-07-21 /pmc/articles/PMC5521151/ /pubmed/28732531 http://dx.doi.org/10.1186/s12905-017-0378-y Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
van Hoogenhuijze, N. E.
Torrance, H. L.
Mol, F.
Laven, J. S. E.
Scheenjes, E.
Traas, M. A. F.
Janssen, C.
Cohlen, B.
Teklenburg, G.
de Bruin, J. P.
van Oppenraaij, R.
Maas, J. W. M.
Moll, E.
Fleischer, K.
van Hooff, M. H.
de Koning, C.
Cantineau, A.
Lambalk, C. B.
Verberg, M.
Nijs, M.
Manger, A. P.
van Rumste, M.
van der Voet, L. F.
Preys-Bosman, A.
Visser, J.
Brinkhuis, E.
den Hartog, J. E.
Sluijmer, A.
Jansen, F. W.
Hermes, W.
Bandell, M. L.
Pelinck, M. J.
van Disseldorp, J.
van Wely, M.
Smeenk, J.
Pieterse, Q. D.
Boxmeer, J.C.
Groenewoud, E.R.
Eijkemans, M. J. C.
Kasius, J. C.
Broekmans, F. J. M.
Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title_full Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title_fullStr Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title_full_unstemmed Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title_short Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)
title_sort endometrial scratching in women with implantation failure after a first ivf/icsi cycle; does it lead to a higher live birth rate? the scratch study: a randomized controlled trial (ntr 5342)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521151/
https://www.ncbi.nlm.nih.gov/pubmed/28732531
http://dx.doi.org/10.1186/s12905-017-0378-y
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