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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asherman Syndrome

Intervention / Treatment
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* Drug: Oxiplex/AP gel
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

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 | intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions