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Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

CO2 or Physiological Solution as Distension Medium: Which One is Better in Diagnostic Hysteroscopy?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02958722
Enrollment
2000
Registered
2016-11-08
Start date
2016-11-30
Completion date
2017-04-30
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy, Distension Medium, Pain

Brief summary

The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.

Interventions

Endoscopic procedure to visualize uterine cavity

DRUGcarbon dioxide

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* suspected uterine pathologies * infertility

Exclusion criteria

* pregnancy * severe hypertension, cardiovascular disease or respiratory disease

Design outcomes

Primary

MeasureTime frame
pain discomfort during the procedure assessed through visual analogue scale (VAS)up to six months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026