Reproductive Medicine Unit, University College London Hospital, London, UK
UCL Institute for Women's Health, University College London, London, UK.
BMJ Open. 2021 Oct 29;11(10):e050248. doi: 10.1136/bmjopen-2021-050248.
Adenomyosis can adversely reduce chances of pregnancy in couples undergoing assisted conception. We aim to evaluate the effect of two different downregulation protocols on the reproductive outcomes in women with moderate and severe adenomyosis undergoing frozen-thawed embryo transfer (FTET).
We will conduct a two-armed pragmatic randomised clinical trial comparing modified downregulation with gonadotrophin-releasing hormone (GnRH) analogue for 6 weeks to standard downregulation with GnRH analogue for 1 week prior to FTET. Our primary outcome is clinical pregnancy, defined as a viable intrauterine pregnancy confirmed by ultrasound at greater than 6 weeks gestation, with other secondary reproductive, neonatal and safety outcomes. We aim to randomise 162 patients over 3 years to achieve 80% power for detecting a 20% difference in the primary outcome at 5% significance.
To date there is no consensus on the optimal protocol for management of subfertile women with adenomyosis. Modified downregulation could improve the clinical pregnancy rate by reducing the endometrial inflammatory reaction and/or myometrial contractility and their impact on uterine receptivity in women with moderate and severe adenomyosis of the uterus undergoing FTET. The MODA trial is designed to offer pragmatic, real-life evaluation of the optimal protocol for downregulation for this population during assisted conception treatments. Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the NHS Research Ethics Committees (19/LO/1567).
NCT03946722.
子宫腺肌病可降低接受辅助受孕的夫妇怀孕的机会。我们旨在评估两种不同下调方案对接受冻融胚胎移植（FTET）的中重度子宫腺肌病妇女的生殖结局的影响。
我们将进行一项两臂实用随机临床试验，比较 6 周的改良下调与促性腺激素释放激素（GnRH）类似物与 FTET 前 1 周的标准下调与 GnRH 类似物的效果。我们的主要结局是临床妊娠，定义为通过大于 6 周妊娠的超声确认的可存活宫内妊娠，并伴有其他次要生殖、新生儿和安全性结局。我们计划在 3 年内随机分配 162 名患者，以 5%的显著性水平检测出主要结局 20%差异的 80%效力。
迄今为止，对于患有腺肌病的不孕女性的最佳管理方案尚无共识。改良下调可以通过降低子宫内膜炎症反应和/或子宫肌层收缩性及其对接受 FTET 的中重度子宫腺肌病妇女的子宫容受性的影响，提高临床妊娠率。MODA 试验旨在对接受辅助受孕治疗的这部分人群的下调最佳方案进行实用的、现实生活的评估。我们的研究结果将发表在同行评议的期刊上，并在国内外科学会议和大会上展示。伦理批准由 NHS 研究伦理委员会授予（19/LO/1567）。
NCT03946722。
