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

Not Applicable

Completed

• Conditions: Asherman Syndrome
• Interventions: Drug: Oxiplex/AP gel; Drug: Normal Saline

• Registration Number: NCT01377779
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-09
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-20
• Last Update Submitted: 2011-06-20
• Study First Posted: 2011-06-21
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 and 50 years
• Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

Exclusion Criteria

• Signs of infection upon admission
• Ongoing pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intercoat treatment	Oxiplex/AP gel	women treated by Intercoat gel following hysteroscopy for retained products of conception
Control group	Normal Saline	No additional treatment following hysteroscopy was performed

Primary Outcome Measures

Name	Time	Method
safety of intrauterine application of Intercoat	18 months	women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern

Secondary Outcome Measures

Name	Time	Method
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception	14 months	intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment

Trial Locations

Locations (1)

Asaf Harofe MC; 🇮🇱 Zerifin, Israel