AsthmaINFLAMENCT04626557
Identifying Disease Mechanisms Underlying the Association Between Asthma and Infertility - The INFLammation Asthma Mechanism Endometrium (INFLAME) Study
An observational study of Asthma and Infertility, Female, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Asthma, Infertility, Female
- What is being tested?
- biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: 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 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.
Who may be able to join
- 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:
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- Informed consent.
- 18-40 years.
- Referred to Intra Uterine Insemination (IUI) or in vitro fertilization (IVF)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Respiratory Medicine, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Casper Tidemandsen, MD, +4523497817, casper.tidemandsen.02@regionh.dk
About this study
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.
Read the 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.
- Conditions
- Asthma, Infertility, Female
- Being tested
- biopsy
- Medical subject headings
- Asthma, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
biopsy of the endometrium
| Study group | Role | What they receive |
|---|---|---|
| Women with astma | At the 7th -14th 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. Receives: Procedure: biopsy | |
| Women without asthma | At the 7th - 14th 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. Receives: Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of inflammatory cells
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.
Measured: 6 months
Secondary outcomes (3)
airway inflammation vs inflammation in the endometrium.
Explore associations between airway inflammation and inflammation in the endometrium.
Measured: 6 months
systemic inflammation vs local inflammation
Explore associations between systemic inflammation and local inflammation
Measured: 6 months
Severity
Differences in local inflammation of the endometrium within different severities/phenotypes of asthma.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start2 Nov 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casper Tidemandsen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626557
- Sponsor's protocol ID
- H-20029413
- Acronym
- INFLAME
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Disease Mechanisms Underlying the Association Between Asthma and Infertility - The INFLammation Asthma Mechanism Endometrium (INFLAME) Study
- ClinicalTrials.gov ID
- NCT04626557
- Acronym / sponsor ID
- INFLAME / H-20029413
- Conditions
- Asthma, Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with astma | – | Procedure: biopsyAt the 7th -14th 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. |
| Women without asthma | – | Procedure: biopsyAt the 7th - 14th 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 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 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.
Key inclusion criteria (9 listed)
- Informed consent.
- Diagnosis of asthma.
- 18-40 years.
- Referred to Intra Uterine Insemination (IUI) or in vitro fertilization (IVF)
- Informed consent.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsybiopsy of the endometrium | Procedure or surgery | Women with astma, Women without asthma |
Primary outcome
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.
3 secondary outcomes
airway inflammation vs inflammation in the endometrium.
Time frame: 6 months
systemic inflammation vs local inflammation
Time frame: 6 months
Severity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Undecided. Will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Infertility, Female, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casper Tidemandsen, MD (+4523497817, casper.tidemanden.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type of inflammatory cells (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.