RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.
NCT ID: NCT03370575
Last Updated: 2018-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
900 participants
INTERVENTIONAL
2018-01-31
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ethiodized poppyseed oil
ethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil
the second-generation non-ionic monomer contrast
the second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast
Interventions
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ethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil
the second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
39 Years
FEMALE
No
Sponsors
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Guangzhou Women and Children's Medical Center
OTHER
Responsible Party
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Jing zhang
Director of medical imaging, Guangzhou Women and Children's Medical Center
Principal Investigators
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Jing Zhang
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Women and Children's Medical Center
Locations
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Beijing Haidian District Maternal and Child Care Service Centre
Beijing, Beijing Municipality, China
The second affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou women and children's medical center
Guangzhou, Guangdong, China
Liuzhou Maternal and Child Care Service Centre
Liuzhou, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Maternal and Child Care Service Centre
Wuhan, Hubei, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Lianyungang Maternal and Child Care Service Centre
Lianyungang, Jiangsu, China
Nanjing Maternal and Child Care Service Centre
Nanjing, Jiangsu, China
Dalian Women and Children Medical Center
Dalian, Liaoning, China
Fudan University affiliated Maternity Hospital
Shanghai, Shanghai Municipality, China
Jinjiang Maternal and Child Care Service Centre
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Huichun Wang
Role: primary
Wuquan Wang
Role: primary
Wenhua Qin
Role: primary
Yanli Wang
Role: primary
Weishun Lan
Role: primary
Yi Chen
Role: primary
Wenjian Xu
Role: primary
Yitang Wang
Role: primary
Guofu Zhang
Role: primary
Yichuan Tang
Role: primary
References
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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.
Other Identifiers
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2017102708
Identifier Type: -
Identifier Source: org_study_id
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