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Oil flush may boost fertility in women with blocked tubes

NCT ID NCT04379973

Disease control Sponsor: Dafne Balemans Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether flushing the fallopian tubes with an oil-based dye after a standard foam test can improve the chance of having a baby. About 736 infertile women aged 18-40 with at least one open tube will be randomly assigned to get the extra flush or not. The main goal is to see if more women in the flush group have a live birth within 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 736 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 without pregnancy * have tubal patency of at least one Fallopian tube on Hyfosy Exclusion Criteria: Women with * known iodine allergy * allergy to poppy seed oil * ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction * contra-indication to have tubal patency testing according to the site's indication * active thyroid disorders * untreated subclinical hypothyroidism (TSH\>2.5mIU/L) in case of auto-immune thyroid disease * uterine surgery in the past two months before Hyfosy * a male partner (if applicable) * with a post-wash Total Motile Sperm Count (TMC) \< 1x106 and/or TMC \< 3x106 in the native sperm analysis \[TMC is defined as volume X concentration X (A\* (progressive) + B\* (non progressive) motility in %) divided by 100\] OR * with a history suspect of severe male factor infertility if no sperm sample is available at time of randomisation * 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" * no Belgian national number (RRN/INS) * A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021)

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Conditions

The condition(s) this trial relates to.

female infertility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, female

Contacts and locations

Locations

  • AZ Klina

    Brasschaat, Belgium

  • AZ Sint Jan Brugge

    Bruges, Belgium

  • AZ Sint Lucas

    Ghent, Belgium

  • AZ Turnhout

    Turnhout, Belgium

  • Antwerp University Hospital

    Antwerp, Belgium

  • CHC Mont Légia

    Liège, Belgium

  • CHIREC

    Brussels, Belgium

  • CHR Citadelle

    Liège, Belgium

  • GZA Sint Augustinus

    Antwerp, Belgium

  • Hôpital Erasme

    Lennik, Belgium

  • Imelda

    Bonheiden, Belgium

  • UCL Saint Luc

    Brussels, Belgium

  • UZ Brussel

    Brussels, Belgium

  • UZ Gent

    Ghent, Belgium

  • UZ Leuven

    Leuven, Belgium

  • Ziekenhuis Oost Limburg

    Genk, Belgium

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