Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol
Introduction In vitro fertilisation (IVF) is the treatment of choice for unexplained infertility. Preovulatory uterine flushing could reduce intrauterine debris and inflammatory factors preventing pregnancy and constitute an alternative to IVF. Our objective is to assess the efficacy of preovulatory...
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BMJ Publishing Group
2016-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/6/1/e009897.full |
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| author | Lynne Moore Jessica Lefebvre Sarah Maheux-Lacroix Marie-Ève Bergeron Emmanuel Bujold Sylvie Dodin |
| author_facet | Lynne Moore Jessica Lefebvre Sarah Maheux-Lacroix Marie-Ève Bergeron Emmanuel Bujold Sylvie Dodin |
| author_sort | Lynne Moore |
| collection | DOAJ |
| description | Introduction In vitro fertilisation (IVF) is the treatment of choice for unexplained infertility. Preovulatory uterine flushing could reduce intrauterine debris and inflammatory factors preventing pregnancy and constitute an alternative to IVF. Our objective is to assess the efficacy of preovulatory uterine flushing with physiological saline for the treatment of unexplained infertility.Methods and analysis We will perform a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least 1 year. On the day of their luteinising hormone surge, 192 participants will be randomised in two equal groups to either receive 20 mL of physiological saline by an intrauterine catheter or 10 mL of saline intravaginally. We will assess relative risk of live birth (primary outcome), as well as pregnancy (secondary outcome) over one cycle of treatment. We will report the side effects, complications and acceptability of the intervention.Ethics and dissemination This project was approved by the Ethics committee of the Centre Hospitatlier Universitaire de Quebec (no 2015–1146). Uterine flushing is usually well tolerated by women and would constitute a simple, affordable and minimally invasive treatment for unexplained infertility. We plan to communicate the results of the review by presenting research abstracts at conferences and by publishing the results in a peer-reviewed journal.Trial registration number NCT02539290; Pre-results. |
| format | Article |
| id | doaj-art-91ccae9db2cf4dcdafaab1ddb10ddbff |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-91ccae9db2cf4dcdafaab1ddb10ddbff2025-02-08T12:05:11ZengBMJ Publishing GroupBMJ Open2044-60552016-01-016110.1136/bmjopen-2015-009897Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocolLynne Moore0Jessica Lefebvre1Sarah Maheux-Lacroix2Marie-Ève Bergeron3Emmanuel Bujold4Sylvie Dodin52 Département de médecine sociale et préventive, Université Laval, Québec, Québec, Canada2Centre de recherche du CHU de Québec, Québec, CanadaGynecology and Reproductive Endocrinology, CHU de Québec - Université Laval, Québec City, Québec, CanadaGynecology and Reproductive Endocrinology, CHU de Québec - Université Laval, Québec City, Québec, Canada1Département d`obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada1Département d`obstétrique, gynécologie et reproduction, Université Laval, Québec, CanadaIntroduction In vitro fertilisation (IVF) is the treatment of choice for unexplained infertility. Preovulatory uterine flushing could reduce intrauterine debris and inflammatory factors preventing pregnancy and constitute an alternative to IVF. Our objective is to assess the efficacy of preovulatory uterine flushing with physiological saline for the treatment of unexplained infertility.Methods and analysis We will perform a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least 1 year. On the day of their luteinising hormone surge, 192 participants will be randomised in two equal groups to either receive 20 mL of physiological saline by an intrauterine catheter or 10 mL of saline intravaginally. We will assess relative risk of live birth (primary outcome), as well as pregnancy (secondary outcome) over one cycle of treatment. We will report the side effects, complications and acceptability of the intervention.Ethics and dissemination This project was approved by the Ethics committee of the Centre Hospitatlier Universitaire de Quebec (no 2015–1146). Uterine flushing is usually well tolerated by women and would constitute a simple, affordable and minimally invasive treatment for unexplained infertility. We plan to communicate the results of the review by presenting research abstracts at conferences and by publishing the results in a peer-reviewed journal.Trial registration number NCT02539290; Pre-results.https://bmjopen.bmj.com/content/6/1/e009897.full |
| spellingShingle | Lynne Moore Jessica Lefebvre Sarah Maheux-Lacroix Marie-Ève Bergeron Emmanuel Bujold Sylvie Dodin Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol BMJ Open |
| title | Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol |
| title_full | Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol |
| title_fullStr | Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol |
| title_full_unstemmed | Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol |
| title_short | Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol |
| title_sort | preovulatory uterine flushing with saline as a treatment for unexplained infertility a randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/6/1/e009897.full |
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