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

NCT ID: NCT04744610

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2021-03-31

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

Conditions

Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

4-hour delayed radiographs

The follow-up radiographs was taken 4 h after the HSG operation.

Group Type: OTHER

Add 4-hour delayed radiographs

Intervention Type: DIAGNOSTIC_TEST

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 .

Interventions

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 .

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yimin Zhu

Role: STUDY_CHAIR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yimin Zhu

Role: CONTACT

zhuyim@zju.edu.cn

057189992071

Facility Contacts

Yimin Zhu

Role: primary

zhuyim@zju.edu.cn

057189992071

Other Identifiers

IRB-20200261-R

Identifier Type: -

Identifier Source: org_study_id