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NCT Number: NCT05882188

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AmsterdamUMC

Amsterdam, Netherlands

Location status: Recruiting

Location contact

Danah Kamphuis

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oil-based contrast

Procedure

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

Procedure

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.

Primary outcomes

  1. 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

  1. Time to pregnancy leading to live birth

    Time frame: within six months after randomization

    Calculated from the day of randomization till the first day of the last menstrual bleeding before a positive pregnancy test.

  2. Number of clinical pregnancies

    Time frame: within six months after randomization

    Clinical pregnancy is defined as gestational sac with or without heartbeat visible on ultrasound.

  3. Number of miscarriages

    Time frame: within six months after randomization

    Miscarriage is defined as presence of non-vitality on ultrasound or spontaneous loss off pregnancy

  4. Number of multiple pregnancies

    Time frame: within six months after randomization

    Multiple pregnancy is defined as two or more vital intrauterine pregnancies at 12 weeks gestation.

  5. Number of ectopic pregnancies

    Time frame: within six months after randomization

    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

  6. Number of adverse events

    Time frame: within one months after tubal patency testing

    e.g. infection, intravasation, thyroid dysfunction

  7. Procedural pain scores

    Time frame: Within 15 minutes after tubal patency testing

    measured by Visual Analogue Scale (VAS) on a scale from 0.0 to 10.0 centimeter immediately after tubal patency testing.

  8. Number of fertility treatment cycles

    Time frame: within six months after randomization

    e.g. intra uterine insemination, in vitro fertilization, intracytoplasmatic sperm injection

  9. Number of pregnancy complications

    Time frame: within six months after randomization

    e.g. pregnancy induced hypertension, fetal growth restriction, still birth.

  10. Cost-effectiveness

    Time frame: within six months after randomization

    Comparing the costs (including costs for tubal patency testing and additional fertility treatments) and the effects (chance of live birth)

Study contacts

Contact information is provided by the study sponsor or research team.

Danah Kamphuis, Msc

CONTACT

[email protected]

+312044444567

Velja Mijatovic, Prof

CONTACT

[email protected]

+312044444567

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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)?

Acronym: FOil

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 31, 2023
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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