Infertility
Conditions
Keywords
Infertility, Hysterosalpingography, Oil-soluble contrast medium
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
Interventions
DIAGNOSTIC_TESTAdd 4-hour delayed radiographs
Normal patients only need to take delayed radiographs 24h after HSG operation. In this study, 4-hour delayed radiographs were added to the 24-hour delayed radiographs, so that the patients had to take one more delayed radiographs .
Sponsors
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 38 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in diagnosis of fallopian tube patency 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse events and serious adverse events. | Within one month after hysterosalpingography procedure. | Adverse event levels were assessed according to CTCAE 5.0. |
Countries
China
Contacts
Primary ContactYimin Zhu
Outcome results
None listed