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

Primary Purpose

Asherman Syndrome

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oxiplex/AP gel
Normal Saline
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asherman Syndrome focused on measuring Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asaf Harofe MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intercoat treatment

Control group

Arm Description

women treated by Intercoat gel following hysteroscopy for retained products of conception

No additional treatment following hysteroscopy was performed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2011
Last Updated
June 20, 2011
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01377779
Brief Title
Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions
Official Title
Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome
Keywords
Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intercoat treatment
Arm Type
Experimental
Arm Description
women treated by Intercoat gel following hysteroscopy for retained products of conception
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
No additional treatment following hysteroscopy was performed
Intervention Type
Drug
Intervention Name(s)
Oxiplex/AP gel
Other Intervention Name(s)
Intercoat
Intervention Description
Intrauterine application of Intercoat following hysteroscopy
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Distention media
Intervention Description
No intrauterine application of Intercoat following hysteroscopy
Primary Outcome Measure Information:
Title
safety of intrauterine application of Intercoat
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception
Description
intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment
Time Frame
14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moty Pansky, MD
Organizational Affiliation
Asaf Harofe MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asaf Harofe MC
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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

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