{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T08:15:58Z","timestamp":1765700158195,"version":"3.48.0"},"reference-count":20,"publisher":"BMJ","issue":"5","funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,4,27]]},"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>South Central\u2014Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"ISRCTN23800982\" ext-link-type=\"isrctn\" specific-use=\"clinicaltrial pre-results\">ISRCTN23800982<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-020755","type":"journal-article","created":{"date-parts":[[2018,5,20]],"date-time":"2018-05-20T21:30:18Z","timestamp":1526851818000},"page":"e020755","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"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"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"isrctn23800982","registry":"10.18810\/isrctn","type":"preResults"}],"author":[{"given":"Clare","family":"Pye","sequence":"first","affiliation":[{"name":"Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robin","family":"Chatters","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1538-3521","authenticated-orcid":false,"given":"Judith","family":"Cohen","sequence":"additional","affiliation":[{"name":"Hull Health Trials Unit, University of Hull, Hull"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"Brian","sequence":"additional","affiliation":[{"name":"Patient and Public Involvement (PPI), Fertility Network UK, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying C","family":"Cheong","sequence":"additional","affiliation":[{"name":"University Hospital Southampton NHS Foundation Trust, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Laird","sequence":"additional","affiliation":[{"name":"Biomolecular Sciences Research Centre, Sheffield Hallam University, Sheffield, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lamiya","family":"Mohiyiddeen","sequence":"additional","affiliation":[{"name":"Saint Mary\u2019s Hospital - 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