Infertility, Female
Conditions
Brief summary
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.
Interventions
DRUGthe second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast
DRUGethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging diagnostic quality of hysterosalpingography | procedure (during hysterosalpingography) | defined as mean scores of 3 pictures shot at certain points |
| Ongoing pregnancy | 15 months （6 months for recruitment, 9 months for ongoing pregnancy） | defined as the first day of the last menstrual cycle for the pregnancy is within 6 months after randomization, and after 12 weeks of gestation a positive fetal heartbeat is on ultrasonographic examination |
Countries
China
Contacts
Primary ContactJing Zhang
Outcome results
None listed