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

Infertility Clinical Trial

Official title:

Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744610
• Other study ID #: IRB-20200261-R
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Yimin Zhu
• Phone: 057189992071
• Email: zhuyim[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• Add 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 .

Locations

Country	Name	City	State
China	Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Jiangsu Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse events and serious adverse events.	Adverse event levels were assessed according to CTCAE 5.0.	Within one month after hysterosalpingography procedure.
Primary	Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 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.	The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary	Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 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.	The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary	Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 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.	The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary	Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 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.	The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.