Department of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark
Department of Obstetrics and Gynecology, Roskilde Hospital, Copenhagen, Denmark.
BMJ Open. 2020 Nov 12;10(11):e037041. doi: 10.1136/bmjopen-2020-037041.
Asthma is associated with prolonged time to pregnancy and a higher need for fertility treatment. However, the mechanism underlying this association remains incompletely understood. Previous research points to asthma-driven systemic inflammation also affecting the reproductive organs and thereby fertility. The aim of this study was to determine if treatment with omalizumab prior to fertility treatment will increase pregnancy rate among women with asthma by decreasing the systemic asthma-related inflammation and, by that, to provide insight into the underlying mechanisms.
This is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark. The patients are randomised 1:1 to either omalizumab or placebo. The primary endpoint is the difference in pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy. The secondary endpoints are change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death between groups.
The methods used in this study are of low risk, but if successful, our findings will have a large impact on a large group of patients as infertility and asthma are the most common chronic diseases among the young population. The study has been approved by the Ethics Committee-Danish national research ethics committee (H-18016605) and the Danish Medicines Agency (EudraCT no: 2018-001137-41) and the Danish Data Protection Agency (journal number: VD-2018486 and I-Suite number 6745). The test results will be published regardless of whether they are positive, negative or inconclusive. Publication in international peer-reviewed scientific journals is planned.
NCT03727971.
哮喘与妊娠时间延长和更高的生育治疗需求相关。然而，这种关联的机制仍不完全清楚。先前的研究表明，哮喘驱动的全身炎症也会影响生殖器官，从而影响生育能力。本研究旨在通过降低与哮喘相关的全身炎症来确定在生育治疗前使用奥马珠单抗治疗是否会增加哮喘女性的妊娠率，并深入了解其潜在机制。
这是一项正在进行的前瞻性多中心随机对照试验，计划从丹麦的生育诊所招募 180 名哮喘患者。患者以 1:1 的比例随机分配至奥马珠单抗或安慰剂组。主要终点是妊娠 7 周时超声确认的妊娠率差异。次要终点是痰和血液嗜酸性粒细胞计数的变化、生物标志物的变化、微生物群的变化，以及各组之间的妊娠丢失率、畸形率、子痫前期、早产、出生体重、小于胎龄儿和围产期死亡率。
本研究中使用的方法风险较低，但如果成功，我们的发现将对一大群患者产生重大影响，因为不孕和哮喘是年轻人中最常见的慢性疾病。该研究已获得丹麦国家伦理委员会（H-18016605）和丹麦药品管理局（EudraCT 编号：2018-001137-41）以及丹麦数据保护局（期刊编号：VD-2018486 和 I-Suite 编号 6745）的批准。无论结果是阳性、阴性还是不确定，都将公布测试结果。计划在国际同行评议的科学期刊上发表。
NCT03727971。
