Infertility Clinical Trial
Official title:
A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
Verified date | March 2009 |
Source | IRCCS Burlo Garofolo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
The purpose of this study is:
- to determine whether the choice of the device for performing hysterosalpingography on
the basis of the cervix characteristics can reduce the procedure failure rate;
- to determine whether patient medical history is correlated with the degree of pain
experienced during the HSG procedure.
Status | Completed |
Enrollment | 222 |
Est. completion date | September 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 42 Years |
Eligibility |
Inclusion Criteria: - infertility Exclusion Criteria: - hypersensitivity to iodine or radio-opaque contrast dye - cervicitis - genital bleeding - genital malignancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Burlo Garofolo | Trieste |
Lead Sponsor | Collaborator |
---|---|
IRCCS Burlo Garofolo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | failure rate to complete hysterosalpingography (HSG) | two years | No | |
Secondary | the objective difficulty to perform HSG | two years | No | |
Secondary | the subjective difficulty to perform HSG | two years | No | |
Secondary | the fluoroscopic time | two years | Yes | |
Secondary | the length of the procedure of device application | two years | No | |
Secondary | the volume of contrast medium used | two years | No | |
Secondary | gynecologist satisfaction with the procedure | two years | No | |
Secondary | radiologist satisfaction with the procedure | two years | No | |
Secondary | the percentage of short-term complications | two years | Yes | |
Secondary | the percentage of long-term complications | two years | Yes | |
Secondary | correlation between patient medical history and the degree of pain experienced during the HSG procedure | two years | No | |
Secondary | the degree of pain experienced during the HSG procedure | two years | No |
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