Clinical trial NCT05882188: The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up
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)?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Hysterosalpingography
Hysterosalpingo Foam Sonography
Infertility work-up
Cost-effectiveness
Live birth
Randomized controlled trial
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-05-31
Enrollment: 1102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Number of pregnancies leading to live birth.
timeFrame: within six months after randomization
Secondary outcomes:
measure: Time to pregnancy leading to live birth
timeFrame: within six months after randomization
measure: Number of clinical pregnancies
timeFrame: within six months after randomization
measure: Number of miscarriages
timeFrame: within six months after randomization
measure: Number of multiple pregnancies
timeFrame: within six months after randomization
measure: Number of ectopic pregnancies
timeFrame: within six months after randomization
measure: Number of adverse events
timeFrame: within one months after tubal patency testing
measure: Procedural pain scores
timeFrame: Within 15 minutes after tubal patency testing
measure: Number of fertility treatment cycles
timeFrame: within six months after randomization
measure: Number of pregnancy complications
timeFrame: within six months after randomization
measure: Cost-effectiveness
timeFrame: within six months after randomization
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AmsterdamUMC
Study officials:
References: