The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up

Last updated: April 23, 2024
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

ExEm Foam

Oil-based contrast

Clinical Study ID

NCT05882188
NL83352.018.22
  • Ages 18-42
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 1102
Treatment Group(s): 2
Primary Treatment: ExEm Foam
Phase:
Study Start date:
September 22, 2023
Estimated Completion Date:
June 01, 2027

Study 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.

Connect with a study center

  • AmsterdamUMC

    Amsterdam,
    Netherlands

    Active - Recruiting

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