Last updated on May 2019

HYALOBARRIER GEL ENDO Versus no HYALOBARRIER GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant


Brief description of study

To compare the costs and effects of HYALOBARRIER GEL ENDO versus no HYALOBARRIER GEL ENDO for increasing the chance of conception leading to live birth measured at 30 weeks after randomization in women wishing to become pregnant after surgical removal of intrauterine pathology (endometrial polyps, fibroids with uterine cavity deformation, uterine septa, IUAs or RPOC after miscarriage) by hysteroscopy as an outpatient or in hospital treatment.

Detailed Study Description

Design

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

Participant

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

Treatment

Application of Hyalobarrier gel endo at time of surgery

Control

No application of Hyalobarrier gel endo

Follow up:

short term follow-up: 30 weeks after randomisation long term follow-up: 66 weeks after randomisation

To blind all trial participants, fertility physicians and gynaecologists doing second- or third-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.

Clinical Study Identifier: NCT03880435

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Recruitment Status: Open


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