Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 6, 2016
June 1, 2016
10 months
June 7, 2016
June 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intensity of pain
Intensity of pain assessed by the Visual Analog Scale (VAS)"
up to 30 minutes
Secondary Outcomes (1)
Duration of procedure
intraoperative
Study Arms (2)
Mini-hysteroscopy
EXPERIMENTALA rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm.
Conventional Office Hysteroscopy
ACTIVE COMPARATORA rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm
Interventions
Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic.
. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic.
Eligibility Criteria
You may qualify if:
- Nulliparous patients
You may not qualify if:
- Parous patients, menopausal status, cervical pathology, and previous cervical surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Obstetrics and Gynecology Department,Cairo university
Cairo, Egypt
Related Publications (1)
Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7- and 4-mm hysteroscopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med. 2005 Jan;50(1):45-8.
PMID: 15730173BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Usama M Fouda, M.D, PhD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, PhD
Study Record Dates
First Submitted
June 7, 2016
First Posted
July 6, 2016
Study Start
August 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 6, 2016
Record last verified: 2016-06