Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
Study Overview
Brief Summary
Background of the study:
Hysterosalpingography (HSG) is widely used for the female infertility workup. Many studies have demonstrated that the use of oil-soluble contrast medium (OSCM) ethiodized oil for HSG surgery can improve pregnancy rates. However,The 24-hour delayed radiographs of OSCM HSG also brought some inconvenience to the patients , for example, patients need to make two trips to the hospital.
Objective of the study:
The purpose of this study was to compare OSCM HSGs using 4-hour and 24-hour delayed radiographs in terms of diagnosing tubal patency and identifying the presence of pelvic adhesions.
Study design:
Prospective, open label, self - controlled study
Study population:
Infertile patients scheduled for an OSCM HSG
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 38 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having spontaneous ovulation or inducing ovulation;
- •Infertility lasting for 12 months;
- •Conforms to the indications of hysterosalpingography;
- •Understand and sign the informed consent;
Exclusion Criteria
- •Iodine allergy or hyperthyroidism
- •Acute genital tract inflammation or abnormal leucorrhea examination;
- •Abnormal vaginal bleeding;
- •Fever or preoperative temperature higher than 37.5℃ within 3 days before angiography;
- •Severe insufficiency of cardiopulmonary or liver function;
- •During pregnancy and menstruation;
- •With complications that may cause subjects to be unable to follow the study plan or even endanger the patient's safety or social environment;
- •Patients who are participating in other clinical studies or who are not suitable for inclusion in this study due to other reasons considered by the researchers.
Arms & Interventions
4-hour delayed radiographs
The follow-up radiographs was taken 4 h after the HSG operation.
Intervention: Add 4-hour delayed radiographs (Diagnostic Test)
Outcomes
Primary Outcomes
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
Time Frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
Secondary Outcomes
- Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs(The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.)
- Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs.(The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.)
- Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs(The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.)