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van CCT (UK)

van CCT (UK)

HSG versus HyFoSy: Is er een verschil in pijnscore tussen deze twee tubatesten?

- candidate number12851
- NTR NumberNTR3457
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2012
- Secondary IDsNL40536.029.12 METC VUMC
- Public TitleHSG versus HyFoSy: Is er een verschil in pijnscore tussen deze twee tubatesten?
- Scientific TitleHSG vs. HyFoSy: Is there a difference in VAS painscores between these two tubal patency tests?
- hypothesisThe 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) studiedSubfertility, Tubal patency testing, Pain
- Inclusion criteria1. 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 criteria1. 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2012
- planned closingdate1-dec-2012
- Target number of participants40
- InterventionsTubal patency testing by Hysterosalpingo-Foam Sonography versus Hysterosalpingography.
- Primary outcomeVAS pain scores.
- Secondary outcome1. Procedure time;
2. Difference in costs;
3. Amount of contrast medium needed.
- Timepoints20 minutes post HyFoSy or HSG.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryWhen 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)
- RECORD31-mei-2012 - 11-jun-2012

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