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

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ClinicalTrials.gov Identifier: NCT03370575
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jing zhang, Guangzhou Women and Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: ethiodized poppyseed oil Drug: the second-generation non-ionic monomer contrast Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ethiodized poppyseed oil Drug: ethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil

Active Comparator: the second-generation non-ionic monomer contrast Drug: the second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast




Primary Outcome Measures :
  1. Imaging diagnostic quality of hysterosalpingography [ Time Frame: procedure (during hysterosalpingography) ]
    defined as mean scores of 3 pictures shot at certain points

  2. Ongoing pregnancy [ Time Frame: 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



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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370575


Contacts
Contact: Jing Zhang 13828464628 fejr@foxmail.com

Locations
China, Beijing
Beijing Haidian District Maternal and Child Care Service Centre Recruiting
Beijing, Beijing, China, 100000
Contact: Huichun Wang         
China, Gansu
The second affiliated Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wuquan Wang    13893208515      
China, Guangdong
Guangzhou women and children's medical center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Jing Zhang    13828464628    fejr@foxmail.com   
China, Guangxi
Liuzhou Maternal and Child Care Service Centre Recruiting
Liuzhou, Guangxi, China, 545000
Contact: Wenhua Qin    13768890218      
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Yanli Wang    13838072509      
China, Hubei
Hubei Maternal and Child Care Service Centre Recruiting
Wuhan, Hubei, China, 430000
Contact: Weishun Lan         
China, Hunan
Chenzhou First People's Hospital Recruiting
Chenzhou, Hunan, China, 423000
Contact: Yi Chen         
China, Jiangsu
Lianyungang Maternal and Child Care Service Centre Terminated
Lianyungang, Jiangsu, China, 222002
Nanjing Maternal and Child Care Service Centre Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Wenjian Xu    13813829844      
China, Liaoning
Dalian Women and Children Medical Center Recruiting
Dalian, Liaoning, China, 116000
Contact: Yitang Wang    17709887708      
China, Shanghai
Fudan University affiliated Maternity Hospital Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Guofu Zhang    13916104313      
China, Sichuan
Jinjiang Maternal and Child Care Service Centre Recruiting
Chengdu, Sichuan, China, 610000
Contact: Yichuan Tang         
Mianyang Central Hospital Terminated
Mianyang, Sichuan, China, 621000
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
Principal Investigator: Jing Zhang Guangzhou Women and Children's Medical Center

Responsible Party: Jing zhang, Director of medical imaging, Guangzhou Women and Children's Medical Center, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT03370575     History of Changes
Other Study ID Numbers: 2017102708
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female