Project

Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse. - AGNOHSTIC trial

Code
160S03420
Duration
15 February 2019 → 15 November 2025
Funding
Federal funding: various
Research disciplines
  • Medical and health sciences
    • Gynaecology
    • Reproductive medicine
    • Clinical trials
Keywords
operative hysteroscopy anti-adhesion gel
 
Project description
 

Background

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. This is a uterine cavity keyhole surgery. One of the risks of such an operation is the development of adhesions, which can then have a further effect on fertility. 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. It is packaged as a single-use syringe. It has already been shown that administering the viscous gel after an operative hysteroscopy 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.

Goal

We want to investigate whether the application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) following hysteroscopic removal of intrauterine pathologies in women wishing to conceive, will increase the chance of a successful pregnancy. If a beneficial effect can be demonstrated, cost-effectiveness will also be assessed.

Hypothesis

We assume that the application of HYALOBARRIER® GEL ENDO in the uterus after an operative hysteroscopy will increase the chance of pregnancy and therefore reduces the costs associated with a fertility treatment.

Who

Women between 18 and 47 years with active pregnancy wish (spontaneous or fertility treatment) and a pathology in the uterus (polyp, fibroid, adhesions, septum or placental remnants) which needs to be removed by an operative hysteroscopy.