title: Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02539290; Pre-results.
authors.affiliation: Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Sarah
authors.identifier: http://orcid.org/0000-0003-4187-3708
authors.initials: S
authors.lastname: Maheux-Lacroix
authors.affiliation: Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Dodin
authors.affiliation: Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Lynne
authors.initials: L
authors.lastname: Moore
authors.affiliation: Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bujold
authors.affiliation: Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Jessica
authors.initials: J
authors.lastname: Lefebvre
authors.affiliation: Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
authors.forename: Marie-Ève
authors.initials: MÈ
authors.lastname: Bergeron
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D007246:Infertility / Q000209:etiology / Q000628:therapy*; D050498:Live Birth; D010060:Ovulation; D011247:Pregnancy; D011792:Quebec; D016037:Single-Blind Method; D012965:Sodium Chloride / Q000009:adverse effects / Q000627:therapeutic use*; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000379:methods*; D014599:Uterus; D014621:Vagina; D055815:Young Adult
chemical_list: D012965:Sodium Chloride
keywords: Tubal flushing; Unexplained infertility; Uterine flushing