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

Infertility, Female Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03370575
• Other study ID #: 2017102708
• Status: Recruiting
• Phase: Phase 4
• Start date: January 31, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2018
• Source: Guangzhou Women and Children's Medical Center
• Contact: Jing Zhang
• Phone: 13828464628
• Email: fejr[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• ethiodized poppyseed oil
Hysterosalpingography using ethiodized poppyseed oil
• the second-generation non-ionic monomer contrast
Hysterosalpingography using the second-generation non-ionic monomer contrast

Locations

Country	Name	City	State
China	Beijing Haidian District Maternal and Child Care Service Centre	Beijing	Beijing
China	Jinjiang Maternal and Child Care Service Centre	Chengdu	Sichuan
China	Chenzhou First People's Hospital	Chenzhou	Hunan
China	Dalian Women and Children Medical Center	Dalian	Liaoning
China	Guangzhou women and children's medical center	Guangzhou	Guangdong
China	The second affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	Lianyungang Maternal and Child Care Service Centre	Lianyungang	Jiangsu
China	Liuzhou Maternal and Child Care Service Centre	Liuzhou	Guangxi
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Nanjing Maternal and Child Care Service Centre	Nanjing	Jiangsu
China	Fudan University affiliated Maternity Hospital	Shanghai	Shanghai
China	Hubei Maternal and Child Care Service Centre	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging diagnostic quality of hysterosalpingography	defined as mean scores of 3 pictures shot at certain points	procedure (during hysterosalpingography)
Primary	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)