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

Carmel Medical Center130 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

130

Conditions

Asherman Syndrome Endometrial Polyp Uterine Myoma

Interventions

INTERCOAT administrationDRUG

Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Carmel Medical Center

Haifa, Haifa District, Israel

RECRUITING

Outcomes

Primary Outcomes

Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy

Time frame: one year

Central Contacts

Moran PAZ, M.D.

CONTACT

972-4-8250637 MORANPA@CLALIT.GOV.IL

Yuval Kaufman, M.D.

CONTACT

972-4-8250345 mdykaufman@clalit.org.il

Data from ClinicalTrials.gov

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