Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

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.

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Key information

Conditions

Hysteroscopy, Distension Medium, Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

suspected uterine pathologies
infertility

Exclusion criteria

pregnancy
severe hypertension, cardiovascular disease or respiratory disease

Treatment and study plan

diagnostic hysteroscopy

Procedure

Endoscopic procedure to visualize uterine cavity

physiological solution

Drug

Carbon Dioxide

Drug

Primary outcomes

pain discomfort during the procedure assessed through visual analogue scale (VAS)

Time frame: up to six months

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 8, 2016
Registry last updated: Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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