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

NCT04626557 | Unknown

• 1 other identifier: H-20029413
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Infertility, Female

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• airway inflammation vs inflammation in the endometrium.

  6 months

• systemic inflammation vs local inflammation

  6 months

• Severity

  6 months

Study Arms (2)

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.

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.

Procedure: biopsy

Interventions

biopsy PROCEDURE

biopsy of the endometrium

Women with astma; Women without asthma

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Department of Respiratory Medicine, Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Endometrium biopsis * Blood

MeSH Terms

Conditions

Asthma; Infertility, Female

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Casper Tidemandsen, MD

CONTACT

+4523497817; casper.tidemanden.02@regionh.dk

Charlotte Suppli Ulrik, MD, Dmsd

CONTACT

+4538626089; csulrik@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: November 2, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

DK (1)