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

Infertility Clinical Trial

— FOil  

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)?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882188
• Other study ID #: NL83352.018.22
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: April 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Danah Kamphuis, Msc
• Phone: +312044444567
• Email: FOil[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1102
• Est. completion date: June 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	AmsterdamUMC	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnancies leading to live birth.	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.	within six months after randomization
Secondary	Time to pregnancy leading to live birth	Calculated from the day of randomization till the first day of the last menstrual bleeding before a positive pregnancy test.	within six months after randomization
Secondary	Number of clinical pregnancies	Clinical pregnancy is defined as gestational sac with or without heartbeat visible on ultrasound.	within six months after randomization
Secondary	Number of miscarriages	Miscarriage is defined as presence of non-vitality on ultrasound or spontaneous loss off pregnancy	within six months after randomization
Secondary	Number of multiple pregnancies	Multiple pregnancy is defined as two or more vital intrauterine pregnancies at 12 weeks gestation.	within six months after randomization
Secondary	Number of ectopic pregnancies	Ectopic pregnancy is defined as no intrauterine gestational sac with: an ectopic gestational sac OR HCG concentration >1500 international units per liter (IU/L) with free fluid/ectopic mass on ultrasound or serum HCG >2000IU/L without free fluid/ectopic mass on ultrasound	within six months after randomization
Secondary	Number of adverse events	e.g. infection, intravasation, thyroid dysfunction	within one months after tubal patency testing
Secondary	Procedural pain scores	measured by Visual Analogue Scale (VAS) on a scale from 0.0 to 10.0 centimeter immediately after tubal patency testing.	Within 15 minutes after tubal patency testing
Secondary	Number of fertility treatment cycles	e.g. intra uterine insemination, in vitro fertilization, intracytoplasmatic sperm injection	within six months after randomization
Secondary	Number of pregnancy complications	e.g. pregnancy induced hypertension, fetal growth restriction, still birth.	within six months after randomization
Secondary	Cost-effectiveness	Comparing the costs (including costs for tubal patency testing and additional fertility treatments) and the effects (chance of live birth)	within six months after randomization