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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377779

Enrollment

Registered

2011-06-21

Start date

2009-09-30

Completion date

2011-02-28

Last updated

2011-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asherman Syndrome

Keywords

Oxiplex/AP gel, Prevention of Asherman's syndrome, Intra uterine adhesions

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.

Interventions

DRUGOxiplex/AP gel

Intrauterine application of Intercoat following hysteroscopy

DRUGNormal Saline

No intrauterine application of Intercoat following hysteroscopy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
safety of intrauterine application of Intercoat	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

Measure	Time frame	Description
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception	14 months	intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026