Optimal catheter placement during sonohysterography
Phase 4
- Conditions
- Infertility.Female infertility, unspecified
- Registration Number
- IRCT201309053553N1
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
Inclusion Criteria: Infertile patients who are referred to Royan Institute and undergoing sonohysterography for evaluation of the internal structure of uterine cavity (acquired & congenital abnormalities).
Exclusion criteria: Symptoms or signs of active pelvic infection, Abnormal uterine bleeding ,Women with cervical stenosis, Women with each lesions which disrupts catheterization such as large myoma, Risk factors for endometrial cancer
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain perception. Timepoint: At the time of the Balloon inflation and deflation. Method of measurement: 10-point visual analog pain scale.;Vasovagal reaction rate ( Hypotention, sweating, nausea, vomiting, syncope). Timepoint: from inflation of balloon catheter till 30 minutes after deflation. Method of measurement: touching of pulse , sphygmomanometer, observation of respiration , Termometer.
- Secondary Outcome Measures
Name Time Method Total time required to perform of sonohysterography. Timepoint: During of sonohysterography. Method of measurement: Recording of total time of sonohysterography.;Spontaneous catheter expulsion rate. Timepoint: During of sonohysterography. Method of measurement: Re-Catheter placement rate.;Volume of media required to perform procedure. Timepoint: During of sonohysterography. Method of measurement: Measuring of volume of injected media during sonohysterography.