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

Israel Healthcare Foundation

Status: Unknown

Conditions: Uterine Myoma; Endometrial Polyp; Asherman Syndrome

Treatments: Drug: INTERCOAT administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01637974

CMC-11-0050-CTIL

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

with INTERCOAT

Experimental group

Description:

injection of intercoat into the euterine cavity at the end of hysteroscopy

Treatment:

Drug: INTERCOAT administration

without INTERCOAT

No Intervention group

Description:

without INTERCOAT