Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery

Not Applicable

• Conditions: Asherman Syndrome; Endometrial Polyp; Uterine Myoma
• Interventions: Drug: INTERCOAT administration

• Registration Number: NCT01637974
• Lead Sponsor: Carmel Medical Center

Brief Summary

The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Study Start: 2012-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Age between 18 and 50 years
• Must be able to understand, read and sign consent form

Exclusion Criteria

• Signs of infection upon admission
• Ongoing pregnancy
• Carcinoma of the uterus or cervix
• Recurrent PID
• Women admitted for endometrial ablation
• Women that gave birth 6 weeks ago
• Women participating in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with INTERCOAT	INTERCOAT administration	injection of intercoat into the euterine cavity at the end of hysteroscopy

Primary Outcome Measures

Name	Time	Method
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy	one year

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel