KCE-17002: HYALOBARRIER® GEL ENDO versus kein HYALOBARRIER® GEL ENDO nach Hysteroskopie zur Verbesserung der Fruchtbarkeit bei Frauen mit intrauterinen Erkrankungen, die schwanger werden wollen - AGNOHSTIC-Studie

Trial Description
Title

HYALOBARRIER® GEL ENDO versus no HYALOBARRIER® GEL ENDO following operative hysteroscopy for improving reproductive outcome in women with intrauterine pathology wishing to become pregnant (AGNOHSTIC trial)

Participants (P)

Women aged 18 to 47 years attending Belgian fertility clinics and/or gynaecological departments, scheduled for operative hysteroscopy for endometrial polyps, fibroids with uterine cavity deformation, uterine septa, intrauterine adhesions (IUAs) or retained products of conception (RPOC) and wishing to conceive spontaneously by regular sexual intercourse or before fertility treatment with ovulation induction (OI), controlled ovarian stimulation (COS), intrauterine insemination (IUI) or IVF/ICSI.

Intervention (I)

HYALOBARRIER® GEL ENDO

Control (C)

No application of HYALOBARRIER® GEL ENDO

Outcome (O)

Conception leading to live birth at 30 weeks after randomization

Trial Design

Multi-centre, parallel group, superiority, blinded, randomized controlled trial. Post market study of a Medical Device class III.

Sample Size

420 participants (210 women per group).

Trial duration

4.5 years

Budget

€ 1 336 693,44 VAT included

Status

Open to recruitment

 

Trial team

Sponsor

UZ Gent

Chief Investigator

Prof. Dr. Steven Weyers

 

External Partners

University of Gent

Nordic Pharma

 

Dokumente
Protocol View here
Report Q1 2024
Publication  
REFERENZEN

Clinicaltrials.gov: NCT03880435

Webpage: https://www.agnohstictrial.be/

 

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017