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

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01377779
First received: June 15, 2011
Last updated: June 20, 2011
Last verified: July 2009
  Purpose

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 Intervention
Asherman Syndrome
Drug: Oxiplex/AP gel
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • safety of intrauterine application of Intercoat [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment


Enrollment: 60
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377779

Locations
Israel
Asaf Harofe MC
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Moty Pansky, MD Asaf Harofe MC
  More Information

No publications provided

Responsible Party: Moty Pansky, MD, Asaf Harofe MC
ClinicalTrials.gov Identifier: NCT01377779     History of Changes
Other Study ID Numbers: 2*13/09
Study First Received: June 15, 2011
Last Updated: June 20, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Assaf-Harofeh Medical Center:
Oxiplex/AP gel
Prevention of Asherman's syndrome
Intra uterine adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Gynatresia
Cicatrix
Fibrosis
Pathologic Processes
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014