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Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

INTRODUCTION: Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has...

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Autores principales: Pye, Clare, Chatters, Robin, Cohen, Judith, Brian, Kate, Cheong, Ying C, Laird, Susan, Mohiyiddeen, Lamiya, Skull, Jonathan, Walters, Stephen, Young, Tracey, Metwally, Mostafa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961587/
https://www.ncbi.nlm.nih.gov/pubmed/29780028
http://dx.doi.org/10.1136/bmjopen-2017-020755
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author Pye, Clare
Chatters, Robin
Cohen, Judith
Brian, Kate
Cheong, Ying C
Laird, Susan
Mohiyiddeen, Lamiya
Skull, Jonathan
Walters, Stephen
Young, Tracey
Metwally, Mostafa
author_facet Pye, Clare
Chatters, Robin
Cohen, Judith
Brian, Kate
Cheong, Ying C
Laird, Susan
Mohiyiddeen, Lamiya
Skull, Jonathan
Walters, Stephen
Young, Tracey
Metwally, Mostafa
author_sort Pye, Clare
collection PubMed
description INTRODUCTION: Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies. METHODS AND ANALYSIS: This 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing. Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation. ETHICS AND DISSEMINATION: South Central—Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN23800982; Pre-results.
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spelling pubmed-59615872018-05-30 Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial Pye, Clare Chatters, Robin Cohen, Judith Brian, Kate Cheong, Ying C Laird, Susan Mohiyiddeen, Lamiya Skull, Jonathan Walters, Stephen Young, Tracey Metwally, Mostafa BMJ Open Reproductive Medicine INTRODUCTION: Endometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies. METHODS AND ANALYSIS: This 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing. Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation. ETHICS AND DISSEMINATION: South Central—Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN23800982; Pre-results. BMJ Publishing Group 2018-05-20 /pmc/articles/PMC5961587/ /pubmed/29780028 http://dx.doi.org/10.1136/bmjopen-2017-020755 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Reproductive Medicine
Pye, Clare
Chatters, Robin
Cohen, Judith
Brian, Kate
Cheong, Ying C
Laird, Susan
Mohiyiddeen, Lamiya
Skull, Jonathan
Walters, Stephen
Young, Tracey
Metwally, Mostafa
Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title_full Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title_fullStr Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title_full_unstemmed Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title_short Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial
title_sort induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle ivf/icsi versus usual ivf/icsi therapy: study protocol for a randomised controlled trial
topic Reproductive Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961587/
https://www.ncbi.nlm.nih.gov/pubmed/29780028
http://dx.doi.org/10.1136/bmjopen-2017-020755
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