Fertility influenced by antiTNF treatment MedDRA version: 9.1 Level: LLT Classification code 10016469 Term: Fertility investigations
Conditions
Interventions
Product Name: infliximab
Pharmaceutical Form: Intravenous infusion
Product Name: adalimumab
Pharmaceutical Form: Cutaneous solution
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: - severe disease activity - Crohn`s Disease Activity Index >300 - incapacity to understand the informed consent - previously documented sub/infertility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - semen quality and quantity, inclusive sperm chromatine structure analysis prior and during anti-TNF therapy - time to conception | — |
Countries
Netherlands
Outcome results
None listed