Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Hysteroscopy, Distension Medium, Pain

Treatments: Drug: physiological solution; Procedure: diagnostic hysteroscopy; Drug: carbon dioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT02958722

ISC2

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected uterine pathologies
• infertility

Exclusion criteria

• pregnancy
• severe hypertension, cardiovascular disease or respiratory disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

carbon dioxide

Active Comparator group

Description:

Diagnostic hysteroscopy performed with the carbon dioxide (gas)

Treatment:

Procedure: diagnostic hysteroscopy

Drug: carbon dioxide

physiological solution

Active Comparator group

Description:

Diagnostic hysteroscopy performed with liquid solution (physiologic solution)

Treatment:

Drug: physiological solution

Procedure: diagnostic hysteroscopy