RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.

Guangzhou Women and Children's Medical Center

Status and phase

Unknown

Phase 4

Conditions

Infertility, Female

Treatments

Drug: ethiodized poppyseed oil

Drug: the second-generation non-ionic monomer contrast

Study type

Interventional

Funder types

Other

Identifiers

NCT03370575

2017102708

Details and patient eligibility

About

This study evaluates the difference of imaging diagnostic quality and fertility promoting effect in the diagnosis and treatment of infertility by hysterosalpingography between using ethiodized poppyseed oil and the second-generation non-ionic monomer contrast. Half of participants will receive ethiodized poppyseed oil for hysterosalpingography, while the other half will receive the second-generation non-ionic monomer contrast for hysterosalpingography.

Enrollment

900 estimated patients

Sex

Female

Ages

21 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged between 21 to 39 years, Female;
Had spontaneous menstrual cycle;
Had been trying to conceive for at least 1 year;
There was an indication for evaluation of tubal patency by means of hysterosalpingography.
Understand and sign informed consent.

Exclusion criteria

Known endocrine disorders(e.g., the polycystic ovary syndrome, diabetes, hyperthyroidism, and hyperprolactinemia);
Less than eight menstrual cycles per year;
A high risk of tubal disease (as indicated by a history of pelvic inflammatory disease, previous chlamydia infection, or known endometriosis);
Hyperthyroidism;
Vaginitis, acute or subacute pelvic inflammatory active phase, uterus or fallopian tube tuberculosis;
Uterine or cervical bleeding;
Menelipsis without excluding pregnancy;
Severe heart disease and lung disease;
Body temperature beyond 37.5 ℃ within 3 days before hysterosalpingography;
A total motile sperm count of <1 million sperm per milliliter;
Complications or social environment that can cause patients to fail to follow the study plan and even endanger the patient's safety.