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

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Asherman Syndrome

Treatments: Drug: Normal Saline; Drug: Oxiplex/AP gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01377779

2*13/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intercoat treatment

Experimental group

Description:

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

Treatment:

Drug: Oxiplex/AP gel

Control group

Placebo Comparator group

Description:

No additional treatment following hysteroscopy was performed

Treatment:

Drug: Normal Saline