search
Back to results

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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Add 4-hour delayed radiographs
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Infertility, Hysterosalpingography, Oil-soluble contrast medium

Eligibility Criteria

21 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women's Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

4-hour delayed radiographs

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 6, 2021
Last Updated
February 6, 2021
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04744610
Brief Title
Self-controlled Study Between 4-hour and 24-hour Delayed Radiographs in HSG Using OSCM
Official Title
Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Hysterosalpingography, Oil-soluble contrast medium

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4-hour delayed radiographs
Arm Type
Other
Arm Description
The follow-up radiographs was taken 4 h after the HSG operation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Add 4-hour delayed radiographs
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
Description
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.
Time Frame
The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary Outcome Measure Information:
Title
Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
Description
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.
Time Frame
The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Title
Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
Description
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.
Time Frame
The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Title
Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs.
Description
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.
Time Frame
The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Other Pre-specified Outcome Measures:
Title
The incidence of adverse events and serious adverse events.
Description
Adverse event levels were assessed according to CTCAE 5.0.
Time Frame
Within one month after hysterosalpingography procedure.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yimin Zhu
Phone
057189992071
Email
zhuyim@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yimin Zhu
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Women's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yimin Zhu
Phone
057189992071
Email
zhuyim@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs