The primary hypothesis is that tubal patency test by a HyFoSy procedure is less painful compared to tubal patency test by a hysterosalpingography.
ID
Bron
Verkorte titel
Aandoening
Subfertility, Tubal patency testing, painscores
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
VAS pain scores.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The primary hypothesis is that tubal patency test by a HyFoSy procedure is less painful compared to tubal patency test by a hysterosalpingography.
Onderzoeksopzet
20 minutes post HyFoSy or HSG.
Onderzoeksproduct en/of interventie
Tubal patency testing by Hysterosalpingo-Foam Sonography versus Hysterosalpingography.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3310 |
NTR-old | NTR3457 |
CCMO | NL40536.029.12 |
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OMON | NL-OMON37574 |