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

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ClinicalTrials.gov Identifier: NCT01377779
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asherman Syndrome Drug: Oxiplex/AP gel Drug: Normal Saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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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 Name: Intercoat
Placebo Comparator: Control group
No additional treatment following hysteroscopy was performed
 Drug: Normal Saline
No intrauterine application of Intercoat following hysteroscopy
Other Name: Distention media


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377779


Locations
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Israel
Asaf Harofe MC
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Moty Pansky, MD Asaf Harofe MC
More Information
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Responsible Party: Moty Pansky, MD, Asaf Harofe MC
ClinicalTrials.gov Identifier: NCT01377779    
Other Study ID Numbers: 2*13/09
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: July 2009
Keywords provided by Assaf-Harofeh Medical Center:
Oxiplex/AP gel
Prevention of Asherman's syndrome
Intra uterine adhesions
Additional relevant MeSH terms:
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Gynatresia
Tissue Adhesions
Pathologic Processes
Cicatrix
Fibrosis