{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T22:27:18Z","timestamp":1765837638146,"version":"3.48.0"},"reference-count":12,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T00:00:00Z","timestamp":1616025600000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Fonds de recherche du service de gyn\u00e9cologie reproduction du Centre Hospitalier de l\u2019Universit\u00e9 Laval - CHU de Qu\u00e9bec","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,2,19]]},"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>A therapeutic option frequently proposed for infertility is to proceed first with intrauterine insemination (IUI) cycles. Little is known on the effect of uterine contractions on IUI success rates. We postulated that uterine contractions may help with sperm migration in the women\u2019s genital tract. Our objective is to compare the efficacy of IUI when performed with and without a tenaculum forceps on the cervix.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We are conducting a randomised controlled trial with women aged 18\u201340\u2009years old, diagnosed with primary or secondary infertility due to endometriosis, mild to moderate male factor, unexplained infertility or ovulatory dysfunction, receiving IUI treatments. On the day of their IUI, women will receive standard care treatment plus or minus the planned use of a Pozzi tenaculum forceps on the cervix. Each of the 800 women will be randomised only once for their first three IUI. They will be randomised in one of the following sequences: tenaculum\u2014no tenaculum\u2014tenaculum or, no tenaculum\u2014tenaculum\u2014no tenaculum. We will compare the live birth rate (primary outcome) and the clinical pregnancy rate (secondary outcome) after IUI treatment. We also plan on assessing global satisfaction of women, pain levels felt during IUI and discrepancies in primary and secondary outcomes in interventions performed by attendings compared with trainees.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This research project was approved by the Centre Hospitalier Universitaire de Qu\u00e9bec\u2019s ethics review board (no 2018\u20134084). Pozzi tenaculum application is associated with mild pain, estimated at 33 on a Visual Analogue Scale ranging from 0 to 100. We plan on publishing an article to present our findings in a peer-reviewed journal as well as presenting the research abstract at 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\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT03435809\">NCT03435809<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-043230","type":"journal-article","created":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T13:15:53Z","timestamp":1616073353000},"page":"e043230","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Impact of a Pozzi tenaculum forceps use on the success rate of intrauterine insemination (IUI) : protocol for a randomised control trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03435809","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2237-9843","authenticated-orcid":false,"given":"Stephanie","family":"Dufour","sequence":"first","affiliation":[{"name":"Obstetrics and Gynecology, CHU de Qu\u00e9bec-Universit\u00e9 Laval, Quebec, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathieu","family":"Viau","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynecology, Sherbrooke Hospital, Sherbrooke, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maxime","family":"C\u00f4t\u00e9","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynecology, CHU de Qu\u00e9bec-Universit\u00e9 Laval, Quebec, Quebec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Lefebvre","sequence":"additional","affiliation":[{"name":"Gynecology and Reproductive Endocrinology, CHU de Qu\u00e9bec - Universit\u00e9 Laval, Qu\u00e9bec City, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Maheux-Lacroix","sequence":"additional","affiliation":[{"name":"Gynecology and Reproductive Endocrinology, CHU de Qu\u00e9bec - Universit\u00e9 Laval, Qu\u00e9bec City, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie-\u00c8ve","family":"Bergeron","sequence":"additional","affiliation":[{"name":"Gynecology and Reproductive Endocrinology, CHU de Qu\u00e9bec - Universit\u00e9 Laval, Qu\u00e9bec City, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,3,18]]},"reference":[{"key":"2025121514222841000_11.3.e043230.1","article-title":"Intrauterine insemination","volume":"15","year":"2009","journal-title":"Hum Reprod Update"},{"key":"2025121514222841000_11.3.e043230.2","doi-asserted-by":"crossref","first-page":"994","DOI":"10.1016\/j.fertnstert.2014.01.009","article-title":"Prognosis factors of pregnancy after intrauterine insemination with the husband\u2019s sperm: conclusions of an analysis of 2,019 cycles","volume":"101","author":"Dinelli","year":"2014","journal-title":"Fertil Steril"},{"key":"2025121514222841000_11.3.e043230.3","doi-asserted-by":"crossref","first-page":"1053","DOI":"10.1080\/00016340903118000","article-title":"Does tenaculum application to the cervix during intrauterine insemination affect pregnancy rates?","volume":"88","author":"Balci","year":"2009","journal-title":"Acta Obstet Gynecol Scand"},{"key":"2025121514222841000_11.3.e043230.4","doi-asserted-by":"crossref","DOI":"10.3349\/ymj.2010.51.6.949","article-title":"The use of tenaculum during intrauterine insemination may not affect the pregnancy outcome","volume":"51","author":"Park","year":"2010","journal-title":"Yonsei Med J"},{"unstructured":"Coll\u00e8ge des m\u00e9decins du Qu\u00e9bec . Les activit\u00e9s de procr\u00e9ation m\u00e9dicalement assist\u00e9e - d\u00e9marche clinique et th\u00e9rapeutique. CMQ 2015:1\u2013138.","key":"2025121514222841000_11.3.e043230.5"},{"doi-asserted-by":"publisher","key":"2025121514222841000_11.3.e043230.6","DOI":"10.1093\/humupd\/dmp048"},{"doi-asserted-by":"publisher","key":"2025121514222841000_11.3.e043230.7","DOI":"10.3109\/01443615.2011.569780"},{"key":"2025121514222841000_11.3.e043230.8","doi-asserted-by":"crossref","first-page":"286","DOI":"10.3109\/14647273.2013.841328","article-title":"Factors predictive of clinical pregnancy in the first intrauterine insemination cycle of 306 couples with favourable female patient characteristics","volume":"16","author":"Aydin","year":"2013","journal-title":"Hum Fertil"},{"doi-asserted-by":"publisher","key":"2025121514222841000_11.3.e043230.9","DOI":"10.1016\/j.fertnstert.2009.04.040"},{"doi-asserted-by":"publisher","key":"2025121514222841000_11.3.e043230.10","DOI":"10.1002\/(SICI)1097-0258(19980730)17:14<1643::AID-SIM869>3.0.CO;2-3"},{"doi-asserted-by":"publisher","key":"2025121514222841000_11.3.e043230.11","DOI":"10.1016\/j.cmpb.2008.03.001"},{"unstructured":"Hoffman BLS , Schorge JO , Schaffer JI . Williams gynecology. 2nd edn. Dallas: McGraw-Hill, 2008.","key":"2025121514222841000_11.3.e043230.12"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-043230","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T22:22:35Z","timestamp":1765837355000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-043230"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3]]},"references-count":12,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2021,3,18]]},"published-print":{"date-parts":[[2021,3]]}},"alternative-id":["10.1136\/bmjopen-2020-043230"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-043230","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2021,3]]}}}