se 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 sixth day of their period bleeding.
- Conditions
- infertility within female asthma patients as a result of systemic inflamation.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-001137-41-DK
- Lead Sponsor
- Hvidovre Hospital. Dep of Respiratory Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 180
* 18-40 years old
•Informed consent
•Diagnosis of asthma with or without allergy
•Infertility due to male factor infertility, tubal factor infertility or unexplained infertility.
•Referred to IVF treatment with or without ICSI
•Willingness to receive treatment with biologic drugs during menstruation period
•Controlled disease with an ACQ = 1.5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Other respiratory diseases than asthma
•Other inflammatory disease or a disease that affects fertility.
•Allergy to the investigational drugs
•Respiratory infections requiring antibiotics or anti-viral treatment within 30 days
•TESA / TESE, Endometriosis
•Infertility due to other reasons than male factor, tubal factor or unexplained infertility
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method