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Study Comparing Oil-Based and Water-Based Contrast Media for Infertility in Women: Iodixanol and Ethyl Esters of Iodised Fatty Acids from Poppyseed Oil

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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 studying infertility in women. The trial compares two types of contrast media used in a procedure called hysterosalpingography (HSG), which is a special X-ray test to examine the inside of the uterus and fallopian tubes. The two contrast media being compared are Visipaque, which is a water-based solution, and Lipiodol Ultra Fluide, which is an oil-based solution. Both of these are injected into the uterus to help doctors see the reproductive organs more clearly during the test.

The purpose of the study is to determine which type of contrast media is more effective in helping women achieve a successful pregnancy. The study will follow participants for up to six months after the procedure to see if they become pregnant and have a live birth. Participants will be randomly assigned to receive either the oil-based or water-based contrast media during their HSG procedure. Some participants may receive a placebo, which is a substance with no active ingredients, to compare the effects.

Throughout the study, various outcomes will be monitored, including the time it takes to become pregnant, any complications from the HSG procedure, and the health of the pregnancy and newborn. The study aims to provide valuable information on the best approach to using contrast media in HSG for women experiencing infertility, ultimately helping to improve their chances of conceiving and having a healthy baby.

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, participants will be randomly assigned to receive either an oil-based or water-based contrast media for a procedure called hysterosalpingography (HSG). This procedure is used to examine the uterus and fallopian tubes.

  2. Step 2

    Hysterosalpingography (HSG) procedure

    Participants will undergo the HSG procedure, where a contrast media is injected into the uterus. The contrast media used will be either VISIPAQUE 320 mg I/ml or Lipiodol Ultra Fluide, 480 mg I/ml, both administered as a solution for injection.

    The procedure is performed to help identify any blockages or abnormalities in the fallopian tubes, which can affect fertility.

  3. Step 3

    Monitoring and follow-up

    After the HSG procedure, participants will be monitored for any immediate complications, such as infection or intravasation (where the contrast media enters the bloodstream).

    Participants will also have their thyroid function checked before and one month after the HSG procedure to ensure there are no adverse effects.

  4. Step 4

    Pregnancy monitoring

    Participants will be monitored for pregnancy outcomes over the next six months. The primary goal is to achieve conception leading to a live birth, with a positive pregnancy test occurring within this period.

    Secondary outcomes include biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, ectopic pregnancy, multiple pregnancy, and time to pregnancy.

  5. Step 5

    Additional fertility treatments

    If necessary, participants may receive additional fertility treatments such as intra-uterine insemination (IUI), in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI) during the study period.

  6. Step 6

    Final assessments

    At the end of the study period, participants will undergo final assessments to evaluate pregnancy outcomes, including birth weight and any pregnancy complications.

    Neonatal outcomes will also be assessed, including the thyroid function of the newborn, which will be determined by a heel prick test.

Who can join the trial?

9 criteria

  • Must have a medical condition of infertility.
  • Must have ovulation disorders, which means having less than 8 menstrual cycles per year.
  • Must be at high risk for tubal pathology. This includes having a history of:
    • Positive chlamydia infection
    • Pelvic inflammatory disease (an infection of the female reproductive organs)
    • Known endometriosis (a condition where tissue similar to the lining inside the uterus grows outside it)
    • Abdominal surgery, such as surgery for an ectopic pregnancy or appendectomy (removal of the appendix)
    • Peritonitis (inflammation of the lining of the abdomen)
    • Must be above 38 years of age.
    • Must be female.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing infertility cannot participate.
  • Only women are eligible to participate; men cannot join the study.
  • Participants must be within a specific age range as defined by the study.
  • Individuals who are part of a vulnerable population may be excluded. This means people who might need special protection or care.
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Investigated drugs

  • Oil-based contrast media

    is a type of liquid used in medical imaging tests. In this trial, it is used during a procedure called hysterosalpingography (HSG), which helps doctors see the inside of a woman's uterus and fallopian tubes. The oil-based contrast media helps to create clear images, which can be important for diagnosing issues related to infertility.

  • Water-based contrast media

    is another type of liquid used in medical imaging tests. Like the oil-based version, it is used during hysterosalpingography (HSG) to help doctors get a clear view of the uterus and fallopian tubes. This helps in identifying any problems that might be affecting a woman's ability to conceive.

What is already known about the treatment

  • Oil-based contrast media

    This medication is administered through a procedure called hysterosalpingography (HSG), where it is injected into the uterus and fallopian tubes to help diagnose infertility in women. Currently, it is being studied in clinical trials to compare its effectiveness with water-based contrast media for improving conception rates. The main therapeutic indication is to assist in diagnosing and potentially enhancing fertility in women who have not been evaluated for specific infertility causes. At the molecular level, oil-based contrast media work by providing a clear image of the reproductive organs on X-rays, which helps doctors identify any blockages or abnormalities. It is classified as a diagnostic agent in pharmacology.

  • Water-based contrast media

    This medication is also used in hysterosalpingography (HSG) and is administered by injecting it into the uterus and fallopian tubes to help diagnose infertility in women. It is being compared to oil-based contrast media in clinical trials to determine which is more effective in aiding conception. The primary therapeutic use is to diagnose and potentially improve fertility in women with unexplained infertility. On a molecular level, water-based contrast media enhance the visibility of the reproductive organs on X-rays, allowing doctors to detect any issues. It is classified as a diagnostic agent in pharmacology.

Investigated diseases

Infertility – Infertility is a condition where an individual is unable to conceive after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural issues, or lifestyle factors. In women, infertility may be due to problems with ovulation, fallopian tube damage, or uterine conditions. In men, it often involves issues with sperm production or function. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional and psychological stress for those affected.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512571-12-00Protocol codeNL66079.029.18Estimated enrolment936 patientsSponsorAmsterdam UMC Stichting

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