A Trial to Compare Three Methods of Performing Hysterosalpingography
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ClinicalTrials.gov Identifier: NCT00870935 |
Recruitment Status
:
Completed
First Posted
: March 27, 2009
Last Update Posted
: December 3, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | March 26, 2009 | |||
First Posted Date ICMJE | March 27, 2009 | |||
Last Update Posted Date | December 3, 2010 | |||
Study Start Date ICMJE | August 2007 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
failure rate to complete hysterosalpingography (HSG) [ Time Frame: two years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00870935 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Trial to Compare Three Methods of Performing Hysterosalpingography | |||
Official Title ICMJE | A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography | |||
Brief Summary | The purpose of this study is:
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Detailed Description | A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice"). The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10. A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered. At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Infertility | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
222 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 25 Years to 42 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00870935 | |||
Other Study ID Numbers ICMJE | RU02/07 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Giuseppe Ricci, IRCCS Burlo Garofolo | |||
Study Sponsor ICMJE | IRCCS Burlo Garofolo | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | IRCCS Burlo Garofolo | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |