NCT01377779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
Last Updated

June 21, 2011

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

June 15, 2011

Last Update Submit

June 20, 2011

Conditions

Asherman Syndrome

Keywords

Oxiplex/AP gelPrevention of Asherman's syndromeIntra uterine adhesions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception

    14 months

Study Arms (2)

Intercoat treatment

EXPERIMENTAL

women treated by Intercoat gel following hysteroscopy for retained products of conception

Drug: Oxiplex/AP gel

Control group

PLACEBO COMPARATOR

No additional treatment following hysteroscopy was performed

Drug: Normal Saline

Interventions

Oxiplex/AP gelDRUG

Intrauterine application of Intercoat following hysteroscopy

Also known as: Intercoat
Intercoat treatment
Normal SalineDRUG

No intrauterine application of Intercoat following hysteroscopy

Also known as: Distention media
Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years
  • Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

You may not qualify if:

  • Signs of infection upon admission
  • Ongoing pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofe MC

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Gynatresia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Moty Pansky, MD

    Asaf Harofe MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 21, 2011

Study Start

September 1, 2009

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

June 21, 2011

Record last verified: 2009-07

Locations

IL(1)