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Clinical Trials/NCT04626557
NCT04626557
Unknown
Not Applicable

Identifying Disease Mechanisms Underlying the Association Between Asthma and Infertility - The INFLammation Asthma Mechanism Endometrium (INFLAME) Study

Hvidovre University Hospital1 site in 1 country30 target enrollmentNovember 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Hvidovre University Hospital
Enrollment
30
Locations
1
Primary Endpoint
type of inflammatory cells
Last Updated
5 years ago

Overview

Brief Summary

To investigate if asthma affects the inflammatory balance of the endometrium and thereby interfere with implantation, as indicated by the characteristics of the inflammatory cells in the endometrium and airways in women with asthma who are referred for IUI or IVF due to infertility, compared to otherwise healthy women who are referred for IUI or IVF due to infertility.

Detailed Description

The link between asthma and fertility may be associated with widespread tissue inflammation, as inflammatory changes are not only affecting the respiratory organs, but also systemically, and here by affecting both the lungs and the reproductive organs in women with asthma. A likely mechanism involved in infertility among asthmatic women seems to be inflammatory changes found in the endometrium of the uterus. Some studies show high number of mast cells, eosinophil granulocytes and basophil granulocytes in the endometrium\[1\]. One study found low values of VEGF in endometrial secretion in women with asthma as a possible cause for subfertility \[2\]. Others assume, that an imbalance of the adaptive immune system (both the Th1 and Th2/TH17 response) is associated with infertility \[3\]. It has been shown that inflammation in the endometrium with a specific combination of cytokines and chemokines is part of successful implantation \[4\]. However, If the inflammatory process is characterized by a less optimal combination of cytokines and chemokines the reproductive outcome may be less successful. The systemic inflammation caused by asthma could offset the balance between the cytokines and chemokines in the endometrium and thereby have negative impact on reproductive outcome. In the present study, our aim is to analyze inflammation in the uterus and in the airways in women with asthma referred to fertility treatment receiving Intrauterine insemination (IUI) or in vitro fertilization (IVF) to characterize and thereby provide knowledge of the mechanisms underlying the association between asthma and reproductive outcomes. In an explorative non-randomized study, including 30 participants divided into two groups: 15 women with asthma and 15 non-asthmatic controls. The patients will go through an asthma work-up (diagnosis, allergy, medication, and inflammation). Menstrual blood will be collected at home using the menstrual cup and at the 7th-14th day cycle day, an endometrium sample from the uterus lining will be obtained together with sputum, as indicators of the system inflammation expressed both in the lungs and the uterus, and blood samples.

Registry
clinicaltrials.gov
Start Date
November 2, 2020
End Date
October 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Casper Tidemandsen

MD

Hvidovre University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

type of inflammatory cells

Time Frame: 6 months

To classify the type of inflammatory cells, (ie. cytokines and inflammatory cells), found in the uterine lining (endometrium) in women with asthma suffering from infertility, compared to non-asthmatic controls.

Secondary Outcomes

  • systemic inflammation vs local inflammation(6 months)
  • airway inflammation vs inflammation in the endometrium.(6 months)
  • Severity(6 months)

Study Sites (1)

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