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

Asherman Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377779
• Other study ID #: 2*13/09
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: June 20, 2011
• Start date: September 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2009
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asherman Syndrome

Intervention

Drug:
• Oxiplex/AP gel
Intrauterine application of Intercoat following hysteroscopy
• Normal Saline
No intrauterine application of Intercoat following hysteroscopy

Locations

Country	Name	City	State
Israel	Asaf Harofe MC	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of intrauterine application of Intercoat	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	18 months	Yes
Secondary	efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception	intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment	14 months	No