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

Infertility Clinical Trial

Official title:
The Cost-effectiveness of Anti-adhesion Treatment With HYALOBARRIER® GEL ENDO Versus no Gel Following the Removal by Hysteroscopy of Endometrial Polyps, Fibroids With Uterine Cavity Deformation, Uterine Septa, Intrauterine Adhesions or Retained Products of Conception for Improving Reproductive Outcome in Women Wishing to Become Pregnant: a Multi-centre, Parallel Group, Superiority, Double-blind, Randomized Controlled Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 receiving the treatment allocation long term follow-up: 66 weeks after receiving the treatment allocation 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03880435
Study type	Interventional
Source	University Hospital, Ghent
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 1, 2019
Completion date	May 31, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.