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

Summary

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.

Conditions

• Infertility
• Polyp Uterus
• Myoma;Uterus
• Adhesion
• Hysteroscopy
• Uterine Septum
• Retained Products of Conception

Interventions

DEVICE

Hyalobarrier® gel endo

Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, peroperatively immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception

Sponsors & Collaborators

• Belgium Health Care Knowledge Centre

  collaborator OTHER_GOV

• Nordic Pharma SAS

  collaborator INDUSTRY

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Health, Innovation and Research Institute (HIRUZ) UZ Ghent

  collaborator UNKNOWN

• University of Liege

  collaborator OTHER

• UCL Bruxelles

  collaborator UNKNOWN

• Jessa hospital, Hasselt

  collaborator UNKNOWN

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Steven Weyers, MD,PhD · Women's Clinic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

47 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2024-06-30

Completion

2025-05-31

Countries

• Belgium

Study Locations