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

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

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

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: Add 4-hour delayed radiographs

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 4-hour delayed radiographs; The follow-up radiographs was taken 4 h after the HSG operation.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (ACTUAL): February 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Infertility; Hysterosalpingography; Oil-soluble contrast medium
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IRB-20200261-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No