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Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol
BACKGROUND: The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been abl...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260784/ https://www.ncbi.nlm.nih.gov/pubmed/32473654 http://dx.doi.org/10.1186/s12884-020-02958-0 |
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author | Izquierdo, Alexandra de la Fuente, Laura Spies, Katharina Rayward, Jennifer López, Lourdes Lora, David Galindo, Alberto |
author_facet | Izquierdo, Alexandra de la Fuente, Laura Spies, Katharina Rayward, Jennifer López, Lourdes Lora, David Galindo, Alberto |
author_sort | Izquierdo, Alexandra |
collection | PubMed |
description | BACKGROUND: The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. METHODS: This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups. DISCUSSION: Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable. TRIAL REGISTRATION: Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov. |
format | Online Article Text |
id | pubmed-7260784 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-72607842020-06-07 Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol Izquierdo, Alexandra de la Fuente, Laura Spies, Katharina Rayward, Jennifer López, Lourdes Lora, David Galindo, Alberto BMC Pregnancy Childbirth Study Protocol BACKGROUND: The effects of endometrial scratching (ES) on embryo implantation have been studied for many years. Several studies have shown better outcomes when performed on patients undergoing intrauterine insemination and in vitro fertilization (IVF) cycles, but many other reports have not been able to find these differences. As far as cycles with donor eggs are concerned, reported evidence is scarce. Our aim in this trial is to determine if ES is useful for those patients undergoing IVF cycles with donor eggs, in order to assure a greater homogeneity in embryo quality and endometrial preparation. METHODS: This single centre randomized controlled trial will include patients undergoing an egg donation cycle, meeting the inclusion criteria and who accept to participate in the study. Once informed consent is signed, patients will be randomly allocated to the study arm (group A) and then receive ES in the luteal phase of the cycle prior to embryo transfer, or the control arm (group B) without any intervention. All cycle data will be collected and analyzed to obtain the clinical pregnancy and the live birth rates in the two groups. DISCUSSION: Several studies have tried to determine the effectiveness of an ES in IVF cycles, but it is still unclear due to the heterogeneity of these reports. The aim of this study is to determine if there are differences in clinical pregnancy rate and live birth rate in egg donor cycles, when comparing an ES performed in the preceding luteal phase versus no intervention, given that embryo quality and endometrial preparation protocols will be comparable. TRIAL REGISTRATION: Ethical approval of version 2.0 of this trial was obtained on the 13th January 2017. It was retrospectively registered on the 5th April 2017 as the ENDOSCRATCH Trial (NCT03108157) in ClinicalTrials.gov. BioMed Central 2020-05-30 /pmc/articles/PMC7260784/ /pubmed/32473654 http://dx.doi.org/10.1186/s12884-020-02958-0 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data. |
spellingShingle | Study Protocol Izquierdo, Alexandra de la Fuente, Laura Spies, Katharina Rayward, Jennifer López, Lourdes Lora, David Galindo, Alberto Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title | Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title_full | Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title_fullStr | Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title_full_unstemmed | Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title_short | Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol |
title_sort | endometrial scratch vs no intervention in egg donation cycles: the endoscratch trial protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260784/ https://www.ncbi.nlm.nih.gov/pubmed/32473654 http://dx.doi.org/10.1186/s12884-020-02958-0 |
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