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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04626557
Acronym
INFLAME
Enrollment
30
Registered
2020-11-12
Start date
2020-11-02
Completion date
2021-10-31
Last updated
2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Infertility, Female

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.

Interventions

PROCEDUREbiopsy

biopsy of the endometrium

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

Inclusion criteria

Asthma n= 15: * Informed consent. * Diagnosis of asthma. * 18-40 years. * Referred to Intra Uterine Insemination (IUI) or in vitro fertilization (IVF) Non-asthmatic n= 15: * Informed consent. * 18-40 years. * Referred to Intra Uterine Insemination (IUI) or in vitro fertilization (IVF)

Exclusion criteria

Asthma only: * Other respiratory diseases than asthma. * Other inflammatory disease or a disease that affects fertility. * Infections requiring antibiotics or anti-viral treatment within 30 days. * Current smokers and/or life-time tobacco exposure \> 10 pack-years. * Endometriosis. * Infertility due to other reasons than male factor, tubal factor or unexplained infertility. * No pelvic inflammatory disease (PID) within the last 6 months. * No contraceptive intrauterine device (IUD), or other contraceptive for the last 6 months. Non-asthmatic controls: * No respiratory diseases. * Other inflammatory disease or a disease that affects fertility. * Infections requiring antibiotics or anti-viral treatment within 30 days. * Current smokers and/or life-time tobacco exposure \> 10 pack-years. * Endometriosis. * Infertility due to other reasons than male factor, tubal factor or unexplained infertility. * No pelvic inflammatory disease (PID) within the last 6 months. * No contraceptive intrauterine device (IUD), or other contraceptive for the last 6 months.

Design outcomes

Primary

MeasureTime frameDescription
type of inflammatory cells6 monthsTo 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

MeasureTime frameDescription
airway inflammation vs inflammation in the endometrium.6 monthsExplore associations between airway inflammation and inflammation in the endometrium.
systemic inflammation vs local inflammation6 monthsExplore associations between systemic inflammation and local inflammation
Severity6 monthsDifferences in local inflammation of the endometrium within different severities/phenotypes of asthma.

Countries

Denmark

Contacts

Primary ContactCasper Tidemandsen, MD
casper.tidemanden.02@regionh.dk+4523497817
Backup ContactCharlotte Suppli Ulrik, MD, Dmsd
csulrik@dadlnet.dk+4538626089

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026