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

NCT04744610 | Unknown

• 1 other identifier: IRB-20200261-R
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Infertility; Hysterosalpingography; Oil-soluble contrast medium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

Other Outcomes (1)

• The incidence of adverse events and serious adverse events.

  Within one month after hysterosalpingography procedure.

Study Arms (1)

4-hour delayed radiographs

OTHER

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

Diagnostic Test: Add 4-hour delayed radiographs

Interventions

Add 4-hour delayed radiographs 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 .

4-hour delayed radiographs

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having spontaneous ovulation or inducing ovulation;
• Infertility lasting for 12 months;
• Conforms to the indications of hysterosalpingography;
• Understand and sign the informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Yimin Zhu

  Women's Hospital School Of Medicine Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yimin Zhu

CONTACT

057189992071; zhuyim@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: February 9, 2021
• Study Start: October 22, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)