To study the influence of anti-TNF therapy on the semen quality of IBD patients
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- changes from the baseline (prior the treatment) semen quality and quantity in
the 3rd and 6th month of the antiTNF treatment
Secondary outcome
not applicable
Background summary
Inflammatory bowel diseases (IBD) affect patients in the reproduction age.
Therefore, the frequently encountered clinical problem concerns the impact of
the disease and therapy on the IBD patients` fertility. Anti-tumor necrosis
factor antibodies (antiTNF) represent a recently introduced therapeutics
effective in IBD. Due to the increasing use of antiTNF in the young IBD
patients` population with conception wish, it is important to study the impact
of these agents on the fertility of IBD patients.
Study objective
To study the influence of anti-TNF therapy on the semen quality of IBD patients
Study design
Observational study without invasive interventions
Study burden and risks
The treatment decision will be guided by standard health care considerations.
The extra burden resulting from the participation in this study will include:
- donation of the sperm for semen analysis prior the treatment with antiTNF, in
the 3rd and 6th month of the treatment and give blood for hormonal analysis.
- filling out the disease activity questionnaire at the inclusion and
subsequently every three months during the follow-up
- outpatient clinic visits every three months, in total 3 times
- venepuncture at every outpatient visit
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- male IBD patients with an absolute indication and no contra-indication for anti-TNF medication
- age between 18 and 50 years
- informed consent
Exclusion criteria
- severe disease activity - Crohn`s Disease Activity Index >300
- incapacity to understand the informed consent
- previously documented sub/infertility
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-005619-16-NL |
| CCMO | NL24890.078.09 |