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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ethiodized poppyseed oil | Experimental |
| |
| the second-generation non-ionic monomer contrast | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethiodized poppyseed oil | Drug | Hysterosalpingography using ethiodized poppyseed oil |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Zhang | Contact | 13828464628 | fejr@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang | Guangzhou Women and Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Haidian District Maternal and Child Care Service Centre | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35399811 | Derived | Zhang J, Lan W, Wang Y, Chen K, Zhang G, Yang W, Chen H, Xu W, Ma J, Qin W, Zhang Y, Wang W, Wang H, Dong Z, Wang Y, Chen Y, Gang N, Tang Y. Ethiodized poppyseed oil-based contrast medium is superior to water-based contrast medium during hysterosalpingography regarding image quality improvement and fertility enhancement: A multicentric, randomized and controlled trial. EClinicalMedicine. 2022 Apr 5;46:101363. doi: 10.1016/j.eclinm.2022.101363. eCollection 2022 Apr. |
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It is not yet known if there will be a plan to make IPD available.
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| the second-generation non-ionic monomer contrast | Drug | Hysterosalpingography using the second-generation non-ionic monomer contrast |
|
| The second affiliated Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
|
| Guangzhou women and children's medical center | Recruiting | Guangzhou | Guangdong | 510623 | China |
|
| Liuzhou Maternal and Child Care Service Centre | Recruiting | Liuzhou | Guangxi | 545000 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Hubei Maternal and Child Care Service Centre | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Chenzhou First People's Hospital | Recruiting | Chenzhou | Hunan | 423000 | China |
|
| Lianyungang Maternal and Child Care Service Centre | Terminated | Lianyungang | Jiangsu | 222002 | China |
| Nanjing Maternal and Child Care Service Centre | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Dalian Women and Children Medical Center | Recruiting | Dalian | Liaoning | 116000 | China |
|
| Fudan University affiliated Maternity Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Jinjiang Maternal and Child Care Service Centre | Recruiting | Chengdu | Sichuan | 610000 | China |
|
| Mianyang Central Hospital | Terminated | Mianyang | Sichuan | 621000 | China |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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