Clinical trial NCT03370575: RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility, Female
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 900
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Imaging diagnostic quality of hysterosalpingography
timeFrame: procedure (during hysterosalpingography)
measure: Ongoing pregnancy
timeFrame: 15 months （6 months for recruitment, 9 months for ongoing pregnancy）
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian District Maternal and Child Care Service Centre
state: Beijing
city: Lanzhou
country: China
facility: The second affiliated Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou women and children's medical center
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Maternal and Child Care Service Centre
state: Guangxi
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Hubei Maternal and Child Care Service Centre
state: Hubei
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Lianyungang
country: China
facility: Lianyungang Maternal and Child Care Service Centre
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Service Centre
state: Jiangsu
city: Dalian
country: China
facility: Dalian Women and Children Medical Center
state: Liaoning
city: Shanghai
country: China
facility: Fudan University affiliated Maternity Hospital
state: Shanghai
city: Chengdu
country: China
facility: Jinjiang Maternal and Child Care Service Centre
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.