Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
N/A
18 Years
50 Years
18 Years
50 Years
Not Enrolling
Female
Asherman Syndrome, Endometrial Polyp, Uterine Myoma
Female
Asherman Syndrome, Endometrial Polyp, Uterine Myoma
Trial Information
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Outcome Measure:
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
Outcome Time Frame:
one year
Safety Issue:
No
Authority:
Israel: Ministry of Health
Study ID:
CMC-11-0050-CTIL
NCT ID:
NCT01637974
Start Date:
August 2012
Completion Date:
July 2013
Related Keywords:
- Asherman Syndrome
- Endometrial Polyp
- Uterine Myoma
- Myoma
- Leiomyoma
- Myofibroma
- Adenoma
- Uterine Neoplasms
- Polyps
- Gynatresia
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