Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
N/A
18 Years
45 Years
18 Years
45 Years
Open (Enrolling)
Female
Endometrial or Uterine Pathology
Female
Endometrial or Uterine Pathology
Trial Information
Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.
Inclusion Criteria:
- Diagnostic hysteroscopy prescribed either for a case of infertility or in case of doubt
of endometrial / uterine pathology suspected by ultrasound or hysterography.
Exclusion Criteria:
- Current Pregnancy.
- Genital infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)
Outcome Time Frame:
7 months
Safety Issue:
No
Principal Investigator
Stéphanie FAY, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hôpital FOCH 40, rue Worth 92150 Suresnes
Authority:
France : Agence Française de Sécurité Sanitaire des Produits de Santé
Study ID:
2010/12
NCT ID:
NCT01789489
Start Date:
July 2010
Completion Date:
April 2014
Related Keywords:
- Endometrial or Uterine Pathology
- Adenoma
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