|- candidate number||12851|
|- NTR Number||NTR3457|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mei-2012|
|- Secondary IDs||NL40536.029.12 METC VUMC|
|- Public Title||HSG versus HyFoSy: Is er een verschil in pijnscore tussen deze twee tubatesten?|
|- Scientific Title||HSG vs. HyFoSy: Is there a difference in VAS painscores between these two tubal patency tests? |
|- ACRONYM||VAS Study|
|- hypothesis||The primary hypothesis is that tubal patency test by a HyFoSy procedure is less painful compared to tubal patency test by a hysterosalpingography.|
|- Healt Condition(s) or Problem(s) studied||Subfertility, Tubal patency testing, Pain|
|- 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.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-dec-2012|
|- Target number of participants||40|
|- Interventions||Tubal patency testing by Hysterosalpingo-Foam Sonography versus Hysterosalpingography.|
|- Primary outcome||VAS pain scores.|
|- Secondary outcome||1. Procedure time;|
2. Difference in costs;
3. Amount of contrast medium needed.
|- Timepoints||20 minutes post HyFoSy or HSG.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Mw. MD. K. Dreyer|
|- CONTACT for SCIENTIFIC QUERIES||Mw. MD. K. Dreyer|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||31-mei-2012 - 11-jun-2012|