Infertility Clinical Trial
Official title:
A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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