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

Women's Hospital School Of Medicine Zhejiang University

Status

Unknown

Conditions

Infertility

Treatments

Diagnostic Test: Add 4-hour delayed radiographs

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04744610

IRB-20200261-R

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

Female

Ages

21 to 38 years old

Volunteers

No 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.