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Water-versus oliehoudend contrast voor het baarmoederonderzoek.


- candidate number11072
- NTR NumberNTR3270
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2012
- Secondary IDsNL2604401808 MEC AMC
- Public TitleWater-versus oliehoudend contrast voor het baarmoederonderzoek.
- Scientific TitleOil-based contrast versus water based contrast media in the diagnosis of tubal patency at Hysterosalpingography. A Randomized Controlled Trial.
- ACRONYMH2Olie studie
- hypothesisThe primary hypothesis is that flushing of the fallopian tubes is more effective with an oil based contrast medium compared to a water based contrast medium in terms of ongoing pregnancy.
- Healt Condition(s) or Problem(s) studiedSubfertility, Tubal patency testing
- Inclusion criteria1. Age between 18 up to and including 39 years;
2. Subfertility of at least one year;
3. Chlamydia antibody titer (CAT) negative;
4. Low risk of tubal pathology according to the medical history;
5. Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.
- Exclusion criteria1. Endocrino-pathological diseases as: PCOS, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type 1;
2. Known or high risk for tubal pathology, CAT positive;
3. Known contrast (iodine) allergy;
4. Male subfertility defined as a post-wash total motile sperm count < 3x10.6 spermatozoa/ml;
5. If not willing or able to sign the consent form.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2011
- planned closingdate1-okt-2014
- Target number of participants1080
- InterventionsTubal flushing with oil based contrast medium versus water based contrast medium.
- Primary outcomeOngoing pregnancy rates.
- Secondary outcomeLive birth rates, miscariages, ectopic pregnancy and pain scores.
- Timepoints6 months post hysterosalpingography.
- Trial web sitehttp://www.studies-obsgyn.nl/h2olie
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. MD. K. Dreyer
- CONTACT for SCIENTIFIC QUERIESMw. MD. K. Dreyer
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryIn the evaluation of female subfertility, hysterosalpingography (HSG) is an important examination because of its diagnostic value. The procedure delineates the uterine cavity contours and the rugation and the patency of the fallopian tubes. Since the introduction of HSG as a diagnostic test, various contrast media have been used, from water-soluble to oil-soluble, ionic to nonionic, and high osmolarity to low osmolarity.

A possible therapeutic effect of diagnostic tubal patency testing has been debated in the literature for more than 50 years.

There are some small studies that show that flushing with Oil-soluble contrast medium (OSCM) has a significant higher odds ratio of live birth compared to flushing with Water-soluble contrast medium (WSCM). But other small studies showed no significant different in odds ratio of pregnancy or live births after flushing during HSG examination with OSCM or WSCM.

The purpose of this multi centre, randomised controlled trial, is to determine whether at HSG the use of oil-based contrast media results in higher ongoing pregnancy and live birth rates compared to the use of water-based contrast media.
- Main changes (audit trail)7-feb-2017: Changes in primary and secondary outcome-EB

- Primary outcome:
“Ongoing pregnancy rates” changed in
“Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation within the first 6 months after randomisation.”

- Secondary outcome
“Live birth rates, miscariages, ectopic pregnancy and pain scores.” changed in:
“Clinical pregnancy, defined as an ultrasound visible gestational sac.”
“Miscarriage, defined as a spontaneous loss off pregnancy”
“Ectopic pregnancy, defined as an embryo implants outside the uterine cavity.”
“Pregnancy leading to live birth”
“Live birth, defined as the birth of at least one living child.”
“Pain scores after the procedure.”
“Cost calculations of OSCM / WSCM and assisted reproductive technology (ART) treatments.”
- RECORD1-feb-2012 - 7-feb-2017


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