Maheux-Lacroix Sarah, Dodin Sylvie, Moore Lynne, Bujold Emmanuel, Lefebvre Jessica, Bergeron Marie-Ève
Département d'obstétrique, gynécologie et reproduction, Université Laval, Québec, Canada Centre de recherche du CHU de Québec, Québec, Canada.
Centre de recherche du CHU de Québec, Québec, Canada.
BMJ Open. 2016 Jan 6;6(1):e009897. doi: 10.1136/bmjopen-2015-009897.
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.
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.
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.
NCT02539290; Pre-results.
体外受精（IVF）是不明原因不孕症的首选治疗方法。排卵前子宫冲洗可减少阻碍受孕的宫腔内碎片和炎症因子，是体外受精的一种替代方法。我们的目的是评估用生理盐水进行排卵前子宫冲洗治疗不明原因不孕症的疗效。
我们将针对年龄在18至37岁之间、因不明原因不孕症咨询至少1年的连续女性进行一项随机对照试验。在促黄体生成素激增当天，192名参与者将被随机分为两组，一组通过宫腔导管接受20毫升生理盐水，另一组经阴道接受10毫升生理盐水。我们将评估一个治疗周期内活产（主要结局）以及妊娠（次要结局）的相对风险。我们将报告干预措施的副作用、并发症及可接受性。
本项目已获得魁北克大学中心医院伦理委员会批准（编号2015 - 1146）。子宫冲洗通常女性耐受性良好，将成为一种针对不明原因不孕症的简单、经济且微创的治疗方法。我们计划通过在会议上展示研究摘要以及在同行评审期刊上发表结果来交流本综述的结果。
NCT02539290；预结果。
