Self-controlled Study Between 4-hour and 24-hour Delayed Radiographs in HSG Using OSCM

Not Applicable

• Conditions: Infertility
• Interventions: Diagnostic Test: Add 4-hour delayed radiographs

• Registration Number: NCT04744610
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Status Verified: 2021-01
• Study First Submitted: 2021-01-06
• Primary Completion: 2021-02
• Study First Submitted QC: 2021-02-06
• Last Update Submitted: 2021-02-06
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-hour delayed radiographs	Add 4-hour delayed radiographs	The follow-up radiographs was taken 4 h after the HSG operation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Women's Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China