The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oil-based contrast, ExEm Foam.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is, in Infertile Women Undergoing a Basic Fertility Work-up, Tubal Flushing With Oil-based Contrast Medium During Hysterosalpingography (HSG) Cost-effective Compared to Tubal Flushing by Hysterosalpingo-foam Sonography (HyFoSy)?
Overview
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.
Detailed description
Background: The diagnostic work-up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work-up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil-based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water-based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies.
Objectives:The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost-effective. In this study the safety of both strategies will also be compared.
Rationale: The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil-based contrast during HSG a cost-effective strategy.
Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil-based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.
Interventions
- Procedure Oil-based contrast
oil-based contrast fluid, Lipiodol Ultra Fluid. Lipiodol is a solution of iodinated ethyl esters of fatty acids of poppyseed oil. Equivalent to 480 mg iodine per ml. The maximum dosage is 15ml. Lipiodol is produced by Guerbet, France. Lipiodol is FDA approved and registered as contrast agent for HSG. - Procedure ExEm Foam
ExEm Foam which is created by mixing 5ml ExEm-gel and 5ml of purified water. ExEm-gel contains hydroxyethylcellulose and glycerol. The ExEm Foam is distributed by IQ Medical Ventures, the Netherlands. ExEm Foam is FDA approved, CE marked and registered as contrast agent for HyFoSy.
Primary outcome measures
- Number of pregnancies leading to live birth. [Time frame: within six months after randomization]
Secondary outcome measures (10)
- Time to pregnancy leading to live birth [Time frame: within six months after randomization]
- Number of clinical pregnancies [Time frame: within six months after randomization]
- Number of miscarriages [Time frame: within six months after randomization]
- Number of multiple pregnancies [Time frame: within six months after randomization]
- Number of ectopic pregnancies [Time frame: within six months after randomization]
- Number of adverse events [Time frame: within one months after tubal patency testing]
- Procedural pain scores [Time frame: Within 15 minutes after tubal patency testing]
- Number of fertility treatment cycles [Time frame: within six months after randomization]
- Number of pregnancy complications [Time frame: within six months after randomization]
- Cost-effectiveness [Time frame: within six months after randomization]
Eligibility criteria
Inclusion criteria
- Infertile women or women with oligo-or anovulation
- Indication for tubal patency testing during the fertility work-up
- Sufficient understanding of the Dutch or English language
- Signed informed consent
Exclusion criteria
- Severe male factor with a total motile sperm count <3x106ml (pre-washed)
- Known contrast (iodine) allergy
- Women who have had a gynecologic procedure within the last 30 days
- Women with known or suspected reproductive tract neoplasia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- AmsterdamUMC — Amsterdam
Publications
- Kamphuis D, Huijser JPM, van Welie N, Verhoeve HR, Kuijper E, de Bruin JP, van Dongen AJCM, Gielen SCJP, de Krom G, Janse F, Koks CAM, Nap AW, Anema JR, Bosmans JE, Stoker J, van Wely M, Mol BWJ, Mijatovic V, Dreyer K. Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study p PMID 39581724
Identifiers
NCT: NCT05882188 · NL83352.018.22