Evidence map›Paper›PMID 33184076›Full record

ArticleBMJ open2020

Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment: a proof-of-concept study-The PRO-ART study protocol.

Casper Tidemandsen, Elisabeth Juul Gade, Charlotte Suppli Ulrik, Henriette Svarre Nielsen, Birgitte Sophie Oxlund-Mariegaard, Karsten Kristiansen, Nina La Cour Freiesleben, Bugge Nøhr, Hanne Udengaard, Vibeke Backer

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03727971 (Use of Omalizumab Will Increase the Pregnancy Rate, Proof of Concept Study, Where Women With Asthma and Infertility Will be Treated Three Times With Weight and IgE Balanced Dosis at the First Day of Their Period Bleeding), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03727971 phase2completednot on this map

Use of Omalizumab Will Increase the Pregnancy Rate, Proof of Concept Study, Where Women With Asthma and Infertility Will be Treated Three Times With Weight and IgE Balanced Dosis at the First Day of Their Period Bleeding

TypeinterventionalSponsorRigshospitalet, DenmarkRan2019 to 2024Enrolled66ConditionsAsthma, Infertility, FemaleArmsOmalizumab Injection, NaCl
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Casper TidemandsenDepartment of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark casper.tidemandsen.02@regionh.dk.ORCID 0000-0001-6032-6414
Elisabeth Juul GadeDepartment of Obstetrics and Gynecology, Roskilde Hospital, Copenhagen, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Henriette Svarre NielsenDepartment of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark.
Birgitte Sophie Oxlund-MariegaardFertility Clinic, Copenhagen University Hospital, Copenhagen, Denmark.
Karsten KristiansenLaboratory of Genomics and Molecular Biomedicine, Department of Biology, University of Copenhagen, Copenhagen, Denmark.
Nina La Cour FreieslebenDepartment of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark.
Bugge NøhrFertility Clinic, Herlev Hospital, Herlev, Denmark.
Hanne UdengaardFertility Clinic, Herlev Hospital, Herlev, Denmark.
Vibeke BackerCentre for Physical Activity Research, Rigshospitalet, Kobenhavn, Denmark.
University of Copenhagen · DKHerlev Hospital · DKHvidovre Hospital · DKCopenhagen University Hospital · DKRigshospitalet · DKRoskilde Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAsthma 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.

Indexed as

AsthmaPremature BirthAntibodies, Anti-IdiotypicFemaleHumansInfant, NewbornMulticenter Studies as TopicOmalizumabPregnancyProspective StudiesRandomized Controlled Trials as TopicAntibodies, Anti-Idiotypicanti-IgE antibodiesOmalizumabasthmareproductive medicinerespiratory medicine (see thoracic medicine)subfertility

Identifiers

PMID33184076
PMCPMC7662444
OpenAlexW3103031269

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.