NCT01377779

Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions

Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.

Detailed description

Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.

Conditions

• Asherman Syndrome

Interventions

Type	Name	Description
DRUG	Oxiplex/AP gel	Intrauterine application of Intercoat following hysteroscopy
DRUG	Normal Saline	No intrauterine application of Intercoat following hysteroscopy

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-11-01
• Completion: 2011-02-01
• First posted: 2011-06-21
• Last updated: 2011-06-21

Locations

1 site across 1 country: Israel