To determine wether a HyFoSy is a less painful procedure compared to a HSG examination for tubal patency testing
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VAS painscores
Secondary outcome
Procedure time, difference in costs and amount of contrast medium needed
Background summary
Tubal patency testing is part of the fertility work-up. There are several tests
available for tubal patency testing, including laparoscopy with
chromopertubation of the fallopian tubes, hystersalpingography (HSG) or a
Hysterosalpingo-Foam Sonography (HyFoSy).
Our pilot study showed a 75% lower VAS painscore at a HyFoSy procedure compared
to HSG, in patients with proximally blocked fallopian tubes. In this trial we
will determine if tubal patency testing in woman with patent fallopian tubes is
less painfull by a HyFoSy procedure compared to tubal patency testing by a HSG
procedure.
By now a HyFoSy procedure is the only sonographic patency test available.
Compared to a HSG procedure, HyFoSy can easily be performed at the outpatient
ward by a gynaecologist himself, it is without X-Ray loading and seems to be a
less expensive investigation for tubal patency testing.
Study objective
To determine wether a HyFoSy is a less painful procedure compared to a HSG
examination for tubal patency testing
Study design
Randomised Clinical Trial in two centres
Study burden and risks
Known complications of HSG are pain related to the procedure, risk of post
procedural infection and allergic reaction on iodine. Intravasation of contrast
can also result in allergic reactions. If intravasation of contrast medium is
detected the procedure will immediately be abandoned.
No complications or potential risks after a HyFoSy procedure are reported up
till now.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Women between 18 and 41 years old
Low risk for tubal pathology according medical history
Chlamydia Antibody Titre (CAT) negative
Valid indication for tubal patency testing
Exclusion criteria
Iodine allergy
High risk for tubal pathology/ CAT positive
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL40536.029.12 |
| OMON | NL-OMON21432 |