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Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol

Authors :
Lynne Moore
Jessica Lefebvre
Sarah Maheux-Lacroix
Marie-Ève Bergeron
Emmanuel Bujold
Sylvie Dodin
Source :
BMJ Open, Vol 6, Iss 1 (2016)
Publication Year :
2016
Publisher :
BMJ Publishing Group, 2016.

Abstract

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.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
6
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.91ccae9db2cf4dcdafaab1ddb10ddbff
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2015-009897