KCE-191224: Impact on fertility after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, pragmatic trial in infertile women with at least one patent tube at HyFoSy - HYFOIL

Summary (French or Dutch)

Unfortunately, 10 to 15 percent of couples in their reproductive lifetime face fertility problems whereby the three most frequent causes of subfertility are sperm defects, ovulation disorders and pathology of the Fallopian tubes. To diagnose tubal pathology, various diagnostic tests are available. Hysterosalpingography (HSG) consist of the injection of contrast medium from the cervical canal, to the uterus and the tubes under radiographic visualization. A diagnostic laparoscopy (DLS) allows direct visualization of the pelvis, including fallopian tubes, ovaries, and uterus but requires general anesthesia and there is a risk for damage to the intestine and bleeding in the abdomen. Hysterosalpingo-foam sonography (Hyfosy) has been proposed as an alternative for the previous tests as a first line office tubal patency test and is performed under ultrasound guidance. The accuracy of Hyfosy is comparable to that of HSG and the advantages over a DLS and HSG are manifold.

Tubal testing with oil soluble contrast medium (OSCM) could also have a direct therapeutic effect. In a recent large randomized multicenter trial in The Netherlands, it was shown that the live birth rate in infertile women six months after HSG was 11% higher in the group of patients that had an HSG with OSCM compared to water-soluble contrast medium. The problem is however, that the OSCM is administered through HSG, while the field has completely moved away from HSG, and is massively using Hyfosy as a first line test to assess tubal pathology which is more patient friendly.

In this a large multicenter randomized clinical trial, the team will evaluate if flushing the Fallopian tubes with oil-soluble contrast medium after a normal Hyfosy showing 1 or 2 open Fallopian tubes, will increase the live birth rate as compared to no flushing. If there is a positive effect of tubal flushing, then this treatment can be implemented in Belgium prior to the start of a treatment such as insemination or IVF.

Trial Description
Title

Impact on fertility 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 (HyFoSy)

Participants (P)

Adult women between 18 and 40 years of age with infertility, defined as the lack of conception despite 12 months of unprotected intercourse, and tubal patency of at least one Fallopian tube.

Intervention (I)

Tubal flush with 5-10mL oil-soluble contrast medium (OSCM) (Lipiodol Ultra Fluide®, Guerbet, France) immediately after Hyfosy. The use will be off-label.

Control (C)

No additional intervention after HyFoSy.

Outcome (O)

The occurrence of live birth of at least one baby beyond 22 weeks of gestation, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.

Trial Design

Multicentre two arm 1:1 randomised, open-label comparative pragmatic trial.

Sample Size

736

Trial duration

47 months

Budget

€2 370 000 EUR

Status

Open

 

Trial team

Sponsor

UZA

Chief Investigator

Prof Dr Diane De Neubourg

Participating sites and Investigators

UZ Antwerpen – Dr Diane De Neubourg

UZ Brussel – Dr Christophe Blockeel

UZ Gent – Dr Dominique Stoop

Imelda Ziekenhuis, Bonheiden – Dr Sofie Pelckmans

AZ St Jan, Brugge – Dr Arne Van De Vijver

Cliniques Universitaires St Luc, Bruxelles – Dr Christine Wyns

CHR La Citadelle, Liège – Dr Laurie Henry

Hôpital Erasme, Bruxelles – Dr Anne Delbaere

CHC MontLégia, Liège – Dr Goffioul

Chirec Auderghem + Braine l’Alleud – Dr Barbara Van Elst

UZ Leuven – Dr Sharon Lie Fong

ZOL, Genk – Dr Nathalie Dhont (TBC)

External partner

none

Documents
Protocol  
Report

Q1/2025

Publication

 

References

Clinicaltrials.gov: NCT04379973

Webpage: 

Funding scheme

2019 Investigator led