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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Amsterdam UMC, location VUmc
- Enrollment
- 1102
- Locations
- 1
- Primary Endpoint
- Number of pregnancies leading to live birth.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Prof. Velja Mijatovic
Professor
Amsterdam UMC, location VUmc
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
Outcomes
Primary Outcomes
Number of pregnancies leading to live birth.
Time Frame: within six months after randomization
Pregnancy is defined as a positive pregnancy test, increase in human chorionic gonadotropin (HCG) level or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy.
Secondary Outcomes
- Number of miscarriages(within six months after randomization)
- Number of fertility treatment cycles(within six months after randomization)
- Cost-effectiveness(within six months after randomization)
- Number of adverse events(within one months after tubal patency testing)
- Procedural pain scores(Within 15 minutes after tubal patency testing)
- Number of clinical pregnancies(within six months after randomization)
- Number of multiple pregnancies(within six months after randomization)
- Number of pregnancy complications(within six months after randomization)
- Time to pregnancy leading to live birth(within six months after randomization)
- Number of ectopic pregnancies(within six months after randomization)