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

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: Infertility

Treatments: Procedure: ExEm Foam; Procedure: Oil-based contrast

Study type: Interventional

Funder types: Other

Identifiers

NCT05882188

NL83352.018.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,102 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,102 participants in 2 patient groups

Tubal flushing during HSG with oil-based contrast

Experimental group

Description:

Tubal flushing during HSG HSG will be performed by a gynaecologist, fertility doctor or nurse according to local protocols. HSG will be performed in the follicular phase of the cycle. Preferably, HSG is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. After cleaning the vagina and cervix, a vacuum cervix adapter will be applied to the cervix or a Lipiodol resistant balloon catheter or hysterophore will be placed through the cervix. Up to 15ml of Lipiodol Ultra Fluid will be injected into the uterine cavity and its spread directly monitored by fluoroscopy. Six to eight radiographs will be taken and assessed by a gynaecologist or radiologist. The maximum amount of oil-based contrast medium is set at 15ml.

Treatment:

Procedure: Oil-based contrast

Tubal flushing HyFoSy

Active Comparator group

Description:

Tubal flushing during HyFoSy will be performed by a gynaecologist, fertility doctor, sonographer or nurse according to local protocols. HyFoSy will be performed in the follicular phase of the cycle. Preferably, HyFosy is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. During HyFoSy approximately 5-10cc of foam will be introduced through a little cervical balloon-less applicator into the uterine cavity. During infusion of the foam into the uterine cavity, a transvaginal ultrasound will be performed which shows whether the Fallopian tubes are patent. The assessment of the procedure will be done by the one who performed the procedure.

Treatment:

Procedure: ExEm Foam