KCE-191224: Auswirkungen auf die Fertilität nach einer zusätzlichen Spülung der Eileiter mit einem ölbasierten Kontrastmittel: eine randomisierte, multizentrische Studie bei Frauen mit mindestens einem offenen Eileiter, bei denen eine HyFoSy HYFOIL durchg

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

Budget

€2 370 000 EUR

Status

Open

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