Impact of anti-tumor necrosis factors antibodies treatment on fertility of inflammatory bowel diseases male patients
- Conditions
- Fertility influenced by antiTNF treatmentMedDRA version: 9.1Level: LLTClassification code 10016469Term: Fertility investigations
- Registration Number
- EUCTR2008-005619-16-NL
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- male IBD patients with an absolute indication and no contra-indication for anti-TNF medication with (study group 1) or without (study group 2) an active conception wish
- male IBD patients (control group) with no indication for anti-TNF treatment with an active conception wish
- age between 18 and 50 years
- informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- severe disease activity - Crohn`s Disease Activity Index >300
- incapacity to understand the informed consent
- previously documented sub/infertility
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the impact of antiTNF agents on the male inflammatory bowel diseases patients` fertility;Secondary Objective: To assess the outcomes of the pregnancies conceived by fathers under antiTNF treatment;Primary end point(s): Primary outcomes:<br>- semen quality and quantity, inclusive sperm chromatine structure analysis prior and during anti-TNF therapy<br>- time to conception <br><br>
- Secondary Outcome Measures
Name Time Method