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

June 20, 2011 updated by: Assaf-Harofeh Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Asaf Harofe MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intercoat treatment
women treated by Intercoat gel following hysteroscopy for retained products of conception
Drug: Oxiplex/AP gel
Intrauterine application of Intercoat following hysteroscopy
Other Names:
  • Intercoat
Placebo Comparator: Control group
No additional treatment following hysteroscopy was performed
Drug: Normal Saline
No intrauterine application of Intercoat following hysteroscopy
Other Names:
  • Distention media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of intrauterine application of Intercoat
Time Frame: 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
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Moty Pansky, MD, Asaf Harofe MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2*13/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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