The primary objective of the study is to evaluate whether a probabilistic diagnostic approach can replace an approach where the indication for testing for tubal pathology is made with measurement of CAT.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As the study aims to assess whether it is efficient to delay the
hydrolaparoscopy in low risk patients with 6 months, the primary outcome in the
number of ongoing pregnancies that occurs in 6 months. We hypothesize that this
number will not be decreased in the group of women in whom laparoscopy is
delayed.
Secondary outcome
Secondary outcomes are the number of (hydro)laparoscopies, number of patients
in whom the diagnosis tubal pathology has been made, number of patients in whom
the diagnosis tubal pathology has been delayed, and costs.
Background summary
Transvaginal hydrolaparoscopy and diagnostic laparoscopy are tests that are
frequently applied in subfertile patients. They can either diagnose or rule out
the diagnosis tubal pathology with 100% certainty. A disadvantage of these
tests is that they are invasive, and sometimes painful, and that they carry a
small risk of complications, such as bowel perforation, bleeding or infection.
In view of these side effects, it is important to perform laparoscopy only in
patients with a high risk on tubal pathology. The probability of tubal
pathology can either be estimated with measurement of the Chlamydia Antibody
Titer (CAT) or the medical history.
Study objective
The primary objective of the study is to evaluate whether a probabilistic
diagnostic approach can replace an approach where the indication for testing
for tubal pathology is made with measurement of CAT.
Study design
Randomised controlled trial with randomisation of patients with discordant test
results, embedded in a larger cohort study.
Intervention
Couples in whom a probability of tubal pathology based on the medical history
is different from the probability based on CAT, will be randomised for
immediate hydrolaparoscopy or a delay in hydrolaparoscopy of 6 months.
Study burden and risks
Participants have no additional risk as compared to regular care, as the study
compares two forms of regular care.
De Run 4600
5500 MB Veldhoven
Nederland
De Run 4600
5500 MB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Subfertility > 12 months;Probability of spontaneous pregnancy > 30%;Discordant result of medical history and Chlamydia Antibody Titer
Exclusion criteria
Azospermia, knwon tubal pathology
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 | NL19423.015.07 |