{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T05:45:47Z","timestamp":1784699147835,"version":"3.55.0"},"reference-count":27,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T00:00:00Z","timestamp":1733443200000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,11,15]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The global increase in caesarean sections (CS), currently at 21.1% of all deliveries, has led to a rise in uterine scar defects, or \u2018niches\u2019, at the hysterotomy site. These niches, detectable in 13%\u201384% of cases via transvaginal ultrasound (TVS) and 42%\u201384% through sonohysterography (SHG), may contribute to gynaecological complications, including abnormal uterine bleeding, chronic pain and secondary infertility. Niche-associated risks for in vitro fertilisation (IVF) outcomes remain underexplored, and this study aims to evaluate their impact on clinical pregnancy rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre, prospective, non-interventional study will involve 250 women with a history of CS and secondary infertility undergoing IVF in 14 reproductive units of French Hospital. Participants will be assessed using SHG and TVS to determine niche presence (measurements of the length, depth and width of the niche, and residual myometrial thickness (RMT)). A niche is diagnosed by an indentation of at least 2 mm at the site of the caesarean scar, with a large niche defined as RMT &lt;3\u2009mm. The primary outcome is clinical pregnancy rate, with secondary outcomes including live birth rates, biochemical pregnancies and obstetric complications. Multivariate logistic regression will control for confounders. The duration of the inclusion period is estimated to be 42 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol was approved by the relevant French medical review board, \u2018Comit\u00e9 de Protection des Personnes Sud M\u00e9diterran\u00e9e IV\u2019, on 10 November 2020 and recorded prospectively (before the inscription of the first participant) under the number ID-RCB: 2020-A02068-31. The study will be conducted according to the guidelines of the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at relevant meetings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov, ID:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04869007\">NCT04869007<\/jats:ext-link>\n                      . Registered on 16 August 2020.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-092011","type":"journal-article","created":{"date-parts":[[2024,12,7]],"date-time":"2024-12-07T12:05:49Z","timestamp":1733573149000},"page":"e092011","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Impact of caesarean scar defects on the success of assisted human reproduction: the NICHE-ART prospective French cohort study protocol"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04869007","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04869007","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8341-509X","authenticated-orcid":false,"given":"Audrey","family":"Astruc","sequence":"first","affiliation":[{"name":"Department of Gynecology and Obstetrics, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Deseine","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Angers University Hospital, Angers, France"},{"name":"Department of Reproductive Medicine, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Spiers","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magalie","family":"Boguenet","sequence":"additional","affiliation":[{"name":"Department of Reproductive Medicine, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascale","family":"May-Panloup","sequence":"additional","affiliation":[{"name":"Department of Reproductive Medicine, Angers University Hospital, Angers, France"},{"name":"Reproductive Biological Laboratory, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre Emmanuel","family":"Bouet","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Angers University Hospital, Angers, France"},{"name":"Department of Reproductive Medicine, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Legendre","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Angers University Hospital, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,12,7]]},"reference":[{"key":"2025121223495174000_14.12.e092011.1","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2021-005671","article-title":"Trends and projections of caesarean section rates: global and regional estimates","volume":"6","author":"Betran","year":"2021","journal-title":"BMJ Glob Health"},{"key":"2025121223495174000_14.12.e092011.2","unstructured":"Enqu\u00eate nationale p\u00e9rinatale: r\u00e9sultats de l\u2019\u00e9dition 2021, Available: https:\/\/www.santepubliquefrance.fr\/presse\/2022\/enquete-nationale-perinatale-resultats-de-l-edition-2021"},{"key":"2025121223495174000_14.12.e092011.3","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1097\/00004347-199501000-00004","article-title":"Surgical pathology of the lower uterine segment caesarean section scar: is the scar a source of clinical symptoms?","volume":"14","author":"Morris","year":"1995","journal-title":"Int J Gynecol Pathol"},{"key":"2025121223495174000_14.12.e092011.4","doi-asserted-by":"crossref","DOI":"10.1016\/j.bpobgyn.2023.102390","article-title":"The definition, diagnosis, and symptoms of the uterine niche - 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