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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, the Second-generation Non-ionic Monomer Contrast Parallel Control, Multicenter Clinical Study to Evaluate the Imaging Diagnostic Quality and Fertility Promoting Effect of Ethiodized Poppyseed Oil in Hysterosalpingography of Infertile Patients.

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: ethiodized poppyseed oil
* Drug: the second-generation non-ionic monomer contrast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ethiodized poppyseed oil<br> | Drug: ethiodized poppyseed oil<br>* Hysterosalpingography using ethiodized poppyseed oil<br>|
| Active Comparator: the second-generation non-ionic monomer contrast<br> | Drug: the second-generation non-ionic monomer contrast<br>* Hysterosalpingography using the second-generation non-ionic monomer contrast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging diagnostic quality of hysterosalpingography | defined as mean scores of 3 pictures shot at certain points | procedure (during hysterosalpingography) | 
| 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 | 15 months （6 months for recruitment, 9 months for ongoing pregnancy） |