1.To study the prevalence of diagnosed and undiagnosed/untreated coeliac disease in male-female couples visiting an infertility clinic.2. To study the relevance of routine antibody screening for coeliac disease in all patients with infertility…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of infertile females and males in whom coeliac disease is diagnosed in
this study.
Secondary outcome
Gender, age, ethnicity, body mass index and diagnostic category for
infertility.
Background summary
Untreated coeliac disease is found in 4-8% of infertile women visiting
infertility clinics. In male untreated coeliac patients, infertility has been
described in smaller case-series. The pathophysiological mechanism of
infertility in coeliac disease patients is multifactorial and incompletely
understood. Treatment of coeliac disease with a gluten-free diet has been
described that it could restore fertility in both sexes.
Hypothesis: Assisted reproduction techniques may be prevented in a substantial
number of couples visiting a Dutch infertility clinic through active detection
and treatment of coeliac disease.
Study objective
1.To study the prevalence of diagnosed and undiagnosed/untreated coeliac
disease in male-female couples visiting an infertility clinic.
2. To study the relevance of routine antibody screening for coeliac disease in
all patients with infertility visiting an infertility clinic.
Study design
For females, screening for celiac disease has been implemented as part of the
standard diagnostic work-up in the participating infertility clinics. For
males, informed consent will be required to be included in the study.
Detection of CD will be performed through
1. Detection of IgA TTG antibodies in serum as part of the standard diagnostic
work-up for infertility in the infertility clinics of the LUMC and Medical
Centre Haaglanden, Westeinde.
2. In case of a positive serological test, the diagnosis for coeliac disease
will be confirmed by endoscopic small bowel biopsy, after informed consent. CD
is diagnosed if internationally accepted histological criteria for CD are
presented. All CD patients will be invited to start with a GFD.
Odds ratios for coeliac disease will be calculated for gender, age, ethnicity,
body mass index and diagnostic category for infertility.
Study burden and risks
No extra risks will be involved by obtaining 5ml of extra blood. And no extra
venous blood puncture has to be performed for this study because the blood
withdrawal will be implemented as part of the standard diagnostic work-up of
the infertily clinics.
In case of a positive serological test, the diagnosis for coeliac disease will
be confirmed by endoscopic small bowel biopsy after informed consent.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
All consecutive male-female couples attending the infertility clinic for the first time.
Exclusion criteria
Couples that require donor insemination are excluded, because screening for celiac disease will not be possible in the donor.
Design
Recruitment
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 |
|---|---|
| CCMO | NL20939.058.08 |