Comparing oil-based contrast flushing to no flushing for improving fertility

Live Birth After Additional Tubal Flushing With Oil-based Contrast Versus no Additional Flushing: a Randomised, Multicentre, Parallel Group Pragmatic Trial in Infertile Women With at Least One Patent Tube at Hysterosalpingo-foam Sonography

This study is testing if using an oil-based flushing treatment after a fertility test can help women under 40 who have been trying to get pregnant for a year or more to conceive more easily.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 736 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: University Hospital, Antwerp (other)
• Locations: 16 sites (Antwerp and 15 other locations)
• Trial ID: NCT04379973 on ClinicalTrials.gov

What this trial studies

This trial investigates whether additional tubal flushing with an oil-soluble contrast medium can enhance the chances of spontaneous conception in infertile women who have undergone a tubal patency test using ultrasound guidance. The study focuses on women aged 18 to 40 who have not achieved pregnancy after 12 months of unprotected intercourse or after multiple cycles of donor insemination. Participants will be randomly assigned to receive either the oil-based contrast flushing or no additional flushing following their initial tubal patency testing. The goal is to determine if this intervention can significantly improve fertility outcomes.

Who should consider this trial

Good fit: Ideal candidates are infertile women aged 18 to 40 with at least one patent Fallopian tube who have not conceived after 12 months of unprotected intercourse or multiple cycles of donor insemination.

Not a fit: Patients with known allergies to iodine or poppy seed oil, or those with specific ovulation disorders or contraindications to tubal patency testing may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could increase the likelihood of spontaneous conception for women facing infertility.

How similar studies have performed: Other studies have explored similar interventions, but the effectiveness of oil-based contrast flushing specifically in this context remains to be fully established.

Eligibility criteria

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)

Where this trial is running

Antwerp and 15 other locations

• Antwerp University Hospital — Antwerp, Belgium (RECRUITING)
• GZA Sint Augustinus — Antwerp, Belgium (RECRUITING)
• Imelda — Bonheiden, Belgium (RECRUITING)
• AZ Klina — Brasschaat, Belgium (RECRUITING)
• AZ Sint Jan Brugge — Brugge, Belgium (TERMINATED)
• CHIREC — Brussel, Belgium (TERMINATED)
• UCL Saint Luc — Brussel, Belgium (RECRUITING)
• UZ Brussel — Brussel, Belgium (RECRUITING)
• Ziekenhuis Oost Limburg — Genk, Belgium (RECRUITING)
• AZ Sint Lucas — Gent, Belgium (RECRUITING)
• UZ Gent — Gent, Belgium (RECRUITING)
• Hôpital Erasme — Lennik, Belgium (RECRUITING)
• UZ Leuven — Leuven, Belgium (RECRUITING)
• CHC Mont Légia — Liège, Belgium (RECRUITING)
• CHR Citadelle — Liège, Belgium (RECRUITING)
• AZ Turnhout — Turnhout, Belgium (RECRUITING)

Study contacts

• Study coordinator: Diane De Neubourg

Conditions: Infertility, Female