No registrations found.
Source
Brief title
Health condition
Subfertility, Tubal patency testing, painscores
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
VAS pain scores.
Secondary outcome
1. Procedure time;
2. Difference in costs;
3. Amount of contrast medium needed.
Background summary
When a couple search for help because of the inability to conceive after one year of trying, they will attend a fertility clinic and get a fertility work-up at the gynaecologist. Tubal patency testing is part of this fertility work-up. There are several tests available for tubal patency testing, including laparoscopy with chromopertubation of the fallopian tubes, hysterosalpingography (HSG), Hysterosalpingo Contrast Sonography (HyCoSy) and Hysterosalpingo-foam Sonography (HyFoSY).
A commonly used medium for HyCoSy was Echovist, but this medium has become no longer available for patency testing because of a possible allergic reaction on this medium when known with galactose allergy. So that meaned that there was no sonographic tubal patency test available anymore.
In 2007 a new medium (Ex-Em-gel®) for gynaecologic sonography was introduces by GynaecologIQ. This is a non(embryo-) toxic gel, containing hydroxyethylcellulose and glycerol. This medium can be used for sonographic patency testing; Hysterosalpingo-foam Sonography (HyFoSy). During the sonography, a little amount of foam is introduced into the uterine cavity through a little cervical balloon-less applicator, connected to a syringe with foam. The foam is created by rigorously mixing 10 ml ExEm-gel® with 10 ml of purified water in a 20 ml syringe. This recipe turned out to be excellent for creating foam that was sufficiently stable to show echogenicety for at least 5 minutes and for providing sufficient fluid to pass through patent tubes.
Recently Emanuel et al showed in their prospective observational cohort study that HyFoSy is a successful procedure to demonstrate tubal patency as a first step office procedure. In 78 % there was no need for HSG after HyFoSy.
The aim of our study is to investigate if a HyFoSy is less painful compared to the first step office procedure for tubal patency testing: HSG. The fact that 78% of subfertile women, with a low risk of tubal pathology, don’t need HSG. Gives us a need to know if a HyFoSy is less aggravating compared to HSG.
Study objective
The primary hypothesis is that tubal patency test by a HyFoSy procedure is less painful compared to tubal patency test by a hysterosalpingography.
Study design
20 minutes post HyFoSy or HSG.
Intervention
Tubal patency testing by Hysterosalpingo-Foam Sonography versus Hysterosalpingography.
VU University Medical Center<br>
PK 6Z K180<br>
De Boelelaan 1118
K. Dreyer
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4445277
k.dreyer@vumc.nl
VU University Medical Center<br>
PK 6Z K180<br>
De Boelelaan 1118
K. Dreyer
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4445277
k.dreyer@vumc.nl
Inclusion criteria
1. Women between 18-41 years;
2. Low risk for tubal pathology according to medical history;
3. Chlamydia Antibody Titre (CAT) negative;
4. Valid indication for patency testing in the fertility work-up or before intra-uterine insemination treatment.
Exclusion criteria
1. Known or high risk for tubal pathology, CAT positive;
2. Known contrast (iodine) allergy;
3. If not willing or able to sign the informed consent.
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 |
---|---|
NTR-new | NL3310 |
NTR-old | NTR3457 |
CCMO | NL40536.029.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |