Clinical trial NCT04744610: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Infertility
Hysterosalpingography
Oil-soluble contrast medium
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2021-02-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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.

Primary outcomes:
measure: Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
timeFrame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary outcomes:
measure: Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
timeFrame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
measure: Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
timeFrame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
measure: Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs.
timeFrame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Other outcomes:
measure: The incidence of adverse events and serious adverse events.
timeFrame: Within one month after hysterosalpingography procedure.
Locations:
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Yimin Zhu
role: STUDY_CHAIR
References: