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 (KCE-17002)

Summary (Dutch or French)

Intrauterine conditions such as a polyp, fibroid, septum, adhesions or placental remnants can affect women’s fertility. These conditions can be removed by means of an operative hysteroscopy.

One of the risks of such an operation is the development of adhesions, which can then have a further effect on fertility. Various methods were investigated to reduce adhesion formation, such as placing an Intra-Uterine Device or an intrauterine balloon, as well as hormonal treatment. In addition, Hyaluronic acid, a body substance made up of sugar and found in the skin and joints, could also have an anti-adhesion effect. Hyaluronic acid is commercially available as HYALOBARRIER® GEL ENDO. The gel is left in the uterine cavity after the intrauterine disorder has been removed. It has already been shown that administering the gel after hysteroscopic removal of a polyp, fibroid, septum, adhesions or placental remnants results in significantly less adhesion formation and less dense adhesives compared to not administering the gel. There are currently no data available on the effect of this anti-adhesion gel on the chance of pregnancy and the course of pregnancy, and that is what we want to investigate in the AGNOHSTIC trial. The study population concerns women with a desire to have children and the presence of an intrauterine disorder. After operative hysteroscopy, they will pursue pregnancy either in a natural cycle or by means of fertility treatment. If the anti-adhesion gel increases the chance of pregnancy, this will therefore result in savings on the cost associated with fertility treatment.

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

 

Documents
Protocol:  
Report: expected 15/01/2024

 

Publication

 

References

Clinicaltrials.gov:

Webpage: 

Funding scheme

Investigator-led workstream 2017