RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.
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.
1 other identifier
interventional
900
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2018
Typical duration for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJuly 5, 2018
July 1, 2018
1.2 years
November 29, 2017
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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）
Study Arms (2)
ethiodized poppyseed oil
EXPERIMENTALthe second-generation non-ionic monomer contrast
ACTIVE COMPARATORInterventions
Hysterosalpingography using ethiodized poppyseed oil
Hysterosalpingography using the second-generation non-ionic monomer contrast
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Beijing Haidian District Maternal and Child Care Service Centre
Beijing, Beijing Municipality, 100000, China
The second affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangzhou women and children's medical center
Guangzhou, Guangdong, 510623, China
Liuzhou Maternal and Child Care Service Centre
Liuchow, Guangxi, 545000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Hubei Maternal and Child Care Service Centre
Wuhan, Hubei, 430000, China
Chenzhou First People's Hospital
Chenzhou, Hunan, 423000, China
Lianyungang Maternal and Child Care Service Centre
Lianyungang, Jiangsu, 222002, China
Nanjing Maternal and Child Care Service Centre
Nanjing, Jiangsu, 210000, China
Dalian Women and Children Medical Center
Dalian, Liaoning, 116000, China
Fudan University affiliated Maternity Hospital
Shanghai, Shanghai Municipality, 200000, China
Jinjiang Maternal and Child Care Service Centre
Chengdu, Sichuan, 610000, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Related Publications (1)
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.
PMID: 35399811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Zhang
Guangzhou Women and Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical imaging, Guangzhou Women and Children's Medical Center
Study Record Dates
First Submitted
November 29, 2017
First Posted
December 12, 2017
Study Start
January 31, 2018
Primary Completion
May 1, 2019
Study Completion
May 1, 2020
Last Updated
July 5, 2018
Record last verified: 2018-07