An interventional study of Oxiplex/AP gel and Normal Saline in Asherman Syndrome, sponsored by Assaf-Harofeh Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-06-21.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Prevention
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.
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.
49 studies on the registry are indexed under Gynatresia; 17 are open to participants now.
This study's enrollment of 60 is below the median of 95 across 41 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
women treated by Intercoat gel following hysteroscopy for retained products of conception
Drug: Oxiplex/AP gel
No additional treatment following hysteroscopy was performed
Drug: Normal Saline
Intrauterine application of Intercoat following hysteroscopy
Also known as: Intercoat
No intrauterine application of Intercoat following hysteroscopy
Also known as: Distention media
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
Time frame: 18 months
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
Time frame: 14 months
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Assaf-Harofeh Medical Center