TY - JOUR
T1 - Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment
T2 - a proof-of-concept study-The PRO-ART study protocol
AU - Tidemandsen, Casper
AU - Juul Gade, Elisabeth
AU - Ulrik, Charlotte Suppli
AU - Nielsen, Henriette Svarre
AU - Oxlund-Mariegaard, Birgitte Sophie
AU - Kristiansen, Karsten
AU - Freiesleben, Nina La Cour
AU - Nøhr, Bugge
AU - Udengaard, Hanne
AU - Backer, Vibeke
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/11/12
Y1 - 2020/11/12
N2 - INTRODUCTION: 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.METHODS AND ANALYSIS: 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.ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT03727971.
AB - INTRODUCTION: 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.METHODS AND ANALYSIS: 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.ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT03727971.
KW - Antibodies, Anti-Idiotypic
KW - Asthma/drug therapy
KW - Female
KW - Humans
KW - Infant, Newborn
KW - Multicenter Studies as Topic
KW - Omalizumab/therapeutic use
KW - Pregnancy
KW - Premature Birth
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - asthma
KW - subfertility
KW - reproductive medicine
KW - respiratory medicine (see thoracic medicine)
U2 - 10.1136/bmjopen-2020-037041
DO - 10.1136/bmjopen-2020-037041
M3 - Protocol
C2 - 33184076
VL - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 11
M1 - e037041
ER -