Live Birth After Additional Tubal Flushing With Oil-based Contrast Versus no Additional Flushing: (HYFOIL)

  • End date
    Nov 1, 2024
  • participants needed
  • sponsor
    Dafne Balemans
Updated on 4 October 2022


Ten to 15 percent of couples in their reproductive lifetime face fertility problems which is defined by WHO as the absence of pregnancy after minimal 12 months of unprotected sexual intercourse. The three most frequent causes of subfertility are: sperm defects, ovulation disorders and tubal pathology. In order to exclude tubal pathology, tubal patency tests are performed under ultrasound guidance with foam (hysterosalpingo-foam sonography (Hyfosy)) or with contrast/water (hysterosalpingo-contrast sonography (Hycosy)).

This trial will investigate whether tubal flushing with an oil-soluble contrast medium (OSCM) can increase the likelihood of a spontaneous conception after tubal patency testing with Hyfosy under ultrasound guidance compared to no additional flushing in a population of infertile women between 18 and 40 years of age with absence of pregnancy after 12 months of unprotected sexual intercourse or who have three cycles of donor insemination without pregnancy or three ovulatory ovulation induction cycles without pregnancy. The use of Lipiodol Ultra Fluide® is off-label in Hyfosy.

This multicenter, randomised, open-label, comparative and pragmatic trial compares 2 arms which will be randomised 1:1:

  • Intervention group: Tubal flush with 5-10mL oil-soluble contrast medium (Lipiodol Ultra Fluide®, Guerbet, France) immediately after Hyfosy
  • Control group: No additional intervention after Hyfosy The study comprises a screening period of maximum 8 weeks (w-8 to d1), randomisation (w-8 to d1), a start study visit at which the Hyfosy is performed (d1) and a fertility treatment period of 6 months (d1-w26). If the woman is not pregnant at 6 months after Hyfosy, the follow-up will last till 12 months (w52). If the participant is pregnant at 6 months after Hyfosy, the follow-up will last till maximal 4 months after live birth or miscarriage.

The primary endpoint is the occurrence of live birth, with the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy. Secondary endpoints consist of reproductive outcomes, gestational age at delivery, birth weight, neonatal mortality, major congenital anomaly, neonatal outcomes and thyroid function, pregnancy complications, number of complications during or immediately after the intervention, pain score of the Hyfosy and additional flush, thyroid function of the mother, general and disease-specific quality of life.

Condition Infertility, Female
Treatment Lipiodol Ultra Fluide®
Clinical Study IdentifierNCT04379973
SponsorDafne Balemans
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible
if they
are ≥ 18 years and < 40 years
have infertility defined as
lack of conception despite 12 months of unprotected intercourse OR
if they are taking part in a donor sperm insemination programme: three cycles of
donor insemination without pregnancy OR
in case of treated ovulation disorder: three ovulatory ovulation induction cycles
have tubal patency of at least one Fallopian tube on Hyfosy
without pregnancy

Exclusion Criteria

Women with
known iodine allergy
allergy to poppy seed oil
contra-indication to have tubal patency testing according to the site's indication
active thyroid disorders
ovulation disorders defined as less than eight menstrual cycles per year who did not
have three ovulatory cycles after ovulation induction
uterine surgery in the past two months before Hyfosy
untreated subclinical hypothyroidism (TSH>2.5mIU/L) in case of auto-immune thyroid
no Belgian national number (RRN/INS)
a male partner (if applicable) with a post-wash Total Motile Sperm Count (TMC) < 1x106
and/or TMC < 3x106 in the native sperm analysis [TMC is defined as volume X
concentration X (A (progressive) + B (non progressive) motility in %) divided by 100]
an indication for IVF defined as patients who are advised to go to IVF immediately
because of bilateral tubal block, severe male factor infertility, unsolved anovulatory
problems, endometriosis with residual functional problems
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note