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Is Hysterosalpingo-Foam Sonografie (HyFoSy) een kosteneffectief alternatief voor hysterosalpingografie (HSG) als tubadoorgankelijkheidstest in subfertiele vrouwen?


- candidate number19323
- NTR NumberNTR4746
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2014
- Secondary IDsNL50484.029.14 
- Public TitleIs Hysterosalpingo-Foam Sonografie (HyFoSy) een kosteneffectief alternatief voor hysterosalpingografie (HSG) als tubadoorgankelijkheidstest in subfertiele vrouwen?
- Scientific TitleIs Hysterosalpingo-Foam Sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women?
- ACRONYMFOAM Study
- hypothesisWe hypothesize that a strategy of tubal patency testing during the fertility work-up by HyFoSy results in equal diagnostic outcomes and subsequent management decisions, which lead to similar ongoing pregnancy rates as a strategy of tubal testing by HSG, but tor lower cost.
- Healt Condition(s) or Problem(s) studiedTubal patency testing, Subfertility, Cost-effectiveness
- Inclusion criteria- Between 18-41 years
- Subfertile for at least one year.
- Valid indication for patency testing in the fertility work-up or before intra-uterine insemination treatment.
- Exclusion criteria- Anovulation not responding on ovulation induction
- Endometriosis
- Tubal patency testing in the past
- Severe male factor with a Total motile sperm count <1x106/ml
- Known contrast (iodine) allergy
- If not willing or able to sign the informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-nov-2017
- Target number of participants1514
- InterventionsRCT1: Hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) in a random order.
IN case of discordance testresults between HyFoSy and HSG women will be included in RCT 2: Diagnostic laparoscopy with chromopertubation versus expectative management.
- Primary outcomeThe primary outcome is ongoing pregnancy rates leading to live birth within 12-months after inclusion.
- Secondary outcomeThe secondary outcomes are:
- Time to pregnancy
- Clinical pregnancy rate
- Miscarriage rate
- Multiple pregnancy rate
- Preterm birth rate
- Concordance between HyFoSy and HSG
- Sensitivity and specificity of HyFoSy and HSG
- Procedure time of tubal patency test
- Direct and indirect costs
- Preference and pain scores
- TimepointsPrimary outcome: 12 months after inclusion Quality of life questionaires: one day before randomisation, one day after tubal patency tests and after 3, 6 and 12 months after inclusion.
- Trial web sitewww.studies-obsgyn.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. J. van Rijswijk
- CONTACT for SCIENTIFIC QUERIESDrs. J. van Rijswijk
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, IQ Medical Ventures, Delft
- PublicationsN/A
- Brief summaryOBJECTIVE: To investigate if tubal patency testing during the fertility work-up by hysterosalpingo-foam sonography (HyFoSy) is more cost-effective compared to hysterosalpingography (HSG).

HYPOTHESIS: We hypothesize that HyFoSy has comparable diagnostic accuracy as HSG for a 50% lower cost.

STUDY DESIGN: We plan a multicenter prospective study of women undergoing tubal patency testing by HyFoSy and HSG in a random order during fertility work-up (RCT1). Women in this study with discordant test results will be randomized for management strategy based on HyFOSy or HSG resulting in a diagnostic laparoscopy with chromopertubation (DLS) or an management based on the prognostic model of Hunault (RCT2). Data will be used in a model based cost-effectiveness analysis.

STUDY POPULATION: Subfertile women scheduled for tubal patency testing.

INTERVENTIONS: Fertility work-up based on HyFoSy.

STANDARD INTERVENTION TO BE COMPARED TO: Fertility work-up based on HSG.

DESIGN: Women will undergo HyFoSy as well as HSG in a random order. Participants with discordant tests results (and therefore apply for different clinical treatments depending on which test was used), will be randomized for for a management strategy based on HyFoSy or HSG resulting in a DLS or a management based on the prognostic model of Hunault. From these data a strategy of outpatient tubal patency testing based on the new technique HyFoSy will be compared with a strategy of tubal patency testing based on HSG.

OUTCOME MEASURES: Ongoing pregnancy rates within 12 month after inclusion. Costs and effectiveness will be analyzed.

SAMPLE SIZE: We propose a non-inferiority effectiveness trial. Under the assumption of a 7% discordance rate between the results of HyFoSy and HSG, we need to randomize 106 women (power 80%) to demonstrate the non-inferiority of HyFoSy (difference < 2%). Basedon the anticipated 7% discordance rate weneed to include a total of 1514 women in the study.

COST-EFFECTIVENESS ANALYSIS/BUDGET IMPACT ANALYSIS: The average costs and effectiveness of a strategy of tubal patency testing during fertility work up by HyFoSy or HSG as first line test will be compared. Fertility treatment and pregnancy outcomes will be evaluated after a follow-up of 12 months. Assuming that 20.000 HSGs are made annually in the Netherlands and a difference in cost of 100 in favor of HyFoSy, the budget impact will estimates a saving of over 2 million in case of non-inferiority.

TIME SCHEDULE: month 1-3: preparation; month 4-33 inclusion and follow- up; month 34-36 data analyses and reporting.
- Main changes (audit trail)12-apr-2017: changes:

Exclusion criteria NEW:
- Anovulation not responding on ovulation induction
- Endometriosis
- Severe male factor with a Total motile sperm count
- Known contrast (iodine) allergy
- If not willing or able to sign the informed consent

Interventions:
RCT1: Hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) in a random order. In case of discordance test results between HyFoSy and HSG women will be included in RCT 2: management strategy based on HSG or HyFoSy resulting in a diagnostic laparoscopy with chromopertubation or an management according to the prognostic model of Hunault. <1x106/ml

Secondary outcome NEW:
The secondary outcomes are:
- Time to pregnancy
- Clinical pregnancy rate
- Miscarriage rate
- Multiple pregnancy rate
- Preterm birth rate
- Concordance between HyFoSy and HSG
- Direct and indirect costs
- Pain scores

Timepoints NEW:
Primary outcome: 12 months after inclusion. Quality of life questionaires in RCT2: one day after randomisation, and after 3, 6 and 12 months after inclusion.
- RECORD19-aug-2014 - 12-apr-2017


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