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Study on the Effect of Oil-Based Tubal Flushing with Ethyl Esters of Iodised Fatty Acids on Pregnancy in Infertile Women with One Open Fallopian Tube

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on women experiencing infertility, specifically those who have at least one open fallopian tube as confirmed by a procedure called Hysterosalpingo-foam sonography (Hyfosy). The study is investigating whether an additional procedure called tubal flushing with an oil-based contrast can improve the chances of achieving a live birth. The contrast used in this study is called Lipiodol Ultra-Fluide, which is a solution injected into the uterus.

The purpose of the study is to determine if this additional tubal flushing with the oil-based contrast after undergoing Hyfosy can significantly increase the likelihood of a live birth within six months. Participants in the study will be randomly assigned to either receive the additional tubal flushing or not, allowing researchers to compare the outcomes between the two groups.

Throughout the study, participants will be monitored from the first day of their last menstrual cycle in which they conceive, up to six months after undergoing Hyfosy. The main focus is on the occurrence of a live birth during this period. This study aims to provide valuable insights into whether this additional procedure can be beneficial for women facing fertility challenges.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants are women aged 18 to 39 who have experienced infertility for at least 12 months or have undergone specific fertility treatments without success.

    Participants must have at least one open Fallopian tube as confirmed by a procedure called Hysterosalpingo-foam sonography (Hyfosy).

  2. Step 2

    Initial procedure

    Participants undergo Hyfosy, a procedure that uses a special foam to check the openness of the Fallopian tubes. This is part of the standard fertility workup.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups. One group receives additional tubal flushing with an oil-based contrast, while the other group does not receive this additional procedure.

  4. Step 4

    Tubal flushing procedure

    For those in the flushing group, a solution called Lipiodol Ultra-Fluide is used. This is a solution for injection containing ethyl esters of iodised fatty acids from poppyseed oil.

    The solution is administered directly into the uterus through a procedure known as intrauterine use.

  5. Step 5

    Monitoring period

    Participants are monitored for up to 6 months following the initial Hyfosy procedure to track the occurrence of pregnancy and live birth.

    The primary goal is to determine if the additional flushing increases the chances of a live birth within this timeframe.

  6. Step 6

    Completion of study

    The study is expected to conclude by May 31, 2025. Results will be analyzed to assess the effectiveness of the additional tubal flushing procedure.

Who can join the trial?

4 criteria

  • Participants must be infertile women who are undergoing a procedure called Hyfosy as part of their fertility evaluation. Hyfosy is a test that uses a special foam to check if the fallopian tubes are open.
  • Participants must be between the ages of 18 and 39.
  • Participants must have experienced infertility, which means they have not become pregnant after 12 months of trying without using birth control. If they are using donor sperm, they must have tried at least three times without success. If they have a condition affecting ovulation, they must have tried at least three times with treatment but not become pregnant.
  • Participants must have at least one open fallopian tube as shown by the Hyfosy test. An open fallopian tube means that the tube is not blocked and can allow an egg to pass through.

Who cannot join the trial?

4 criteria

  • Women who are not infertile cannot participate.
  • Women who do not have at least one open fallopian tube, as shown by a test called Hysterosalpingo-foam sonography (Hyfosy), cannot participate. This test checks if the fallopian tubes are open by using a special foam.
  • Men cannot participate in this study.
  • Women who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.
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Investigated drugs

Oil-based contrast is used in this trial for additional tubal flushing. This therapy involves using a special oil-based liquid to flush the fallopian tubes. The purpose of this procedure is to potentially improve the chances of a live birth in women who have at least one open fallopian tube. The flushing is done after a procedure called Hysterosalpingo-foam sonography (Hyfosy), which is a type of ultrasound used to check the openness of the fallopian tubes. The trial aims to see if this additional flushing with the oil-based contrast can increase the likelihood of conception and live birth within six months after the Hyfosy procedure.

What is already known about the treatment

Oil-based contrast – This medication is administered through a procedure known as tubal flushing, where it is introduced into the fallopian tubes. It is currently being studied in clinical trials to assess its effectiveness in improving live birth rates in infertile women with at least one open fallopian tube. The main therapeutic indication is to enhance fertility outcomes by potentially increasing the chances of conception. The mechanism of action involves the physical flushing of the fallopian tubes, which may help clear any blockages or debris, thereby facilitating the passage of eggs and sperm. It is classified under contrast agents used in diagnostic imaging, specifically for fertility assessments.

Investigated diseases

Infertility in Women – Infertility in women is a condition where a woman is unable to conceive after a year of regular, unprotected intercourse. It can be due to various factors, including problems with ovulation, damage to the fallopian tubes, or issues with the uterus. In some cases, hormonal imbalances or lifestyle factors may also contribute to infertility. The condition can be temporary or permanent, depending on the underlying cause. Women with at least one patent tube, as determined by Hysterosalpingo-foam sonography, may still have a chance of conception. The progression of infertility varies, and it may require medical evaluation to determine the specific cause.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508896-35-00Protocol codeHYFOILEstimated enrolment736 patientsSponsorAntwerp University Hospital

sourced from the EU Clinical Trials Register and site verification

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