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Completed

NCT Number: NCT01377779

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

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.

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Key information

Conditions

Asherman Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asaf Harofe MC

Ẕerifin, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxiplex/AP gel

Drug

Intrauterine application of Intercoat following hysteroscopy

Other names: Intercoat

normal saline

Drug

No intrauterine application of Intercoat following hysteroscopy

Other names: Distention media

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 21, 2011
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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