3D Ultrasound - Based Hysteroscopy Versus Virtual Hysteroscopy

Not Applicable

Terminated

• Conditions: Endometrial or Uterine Pathology
• Interventions: Device: Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)

• Registration Number: NCT01789489
• Lead Sponsor: Hopital Foch

Brief Summary

To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

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Exclusion Criteria

• Current Pregnancy.
• Genital infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard hysteroscopy	Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)	Standard hysteroscopy
3 dimensional sonohysterography	Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)	3 dimensional sonohysterography

Primary Outcome Measures

Name	Time	Method
Polyps, fibrosis, atrophy, hypertrophy and other uterine pathology detected by 3D sonohysterography (Accuracy of uterine cavity exploration by 3D sonohysterography)	7 months

Trial Locations

Locations (1)

Hôpital FOCH; 🇫🇷 Suresnes, France