Infertility, FemalePhase 4NCT03370575
RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.
A Phase 4 study testing ethiodized poppyseed oil and the second-generation non-ionic monomer contrast in people with Infertility, Female, run by Guangzhou Women and Children's Medical Center at 13 sites in China.
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. Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- ethiodized poppyseed oil and the second-generation non-ionic monomer contrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 13 sitesChina
- Study dates
- 31 Jan 2018to 1 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 11 recruiting
- Recruiting
Beijing Haidian District Maternal and Child Care Service Centre
Beijing, Beijing Municipality, 100000
Huichun Wang
- Recruiting
Jinjiang Maternal and Child Care Service Centre
Chengdu, Sichuan, 610000
Yichuan Tang
- Recruiting
Chenzhou First People's Hospital
Chenzhou, Hunan, 423000
Yi Chen
- Recruiting
Dalian Women and Children Medical Center
Dalian, Liaoning, 116000
Yitang Wang, 17709887708
- Recruiting
Guangzhou women and children's medical center
Guangzhou, Guangdong, 510623
Jing Zhang, 13828464628, fejr@foxmail.com
- Recruiting
The second affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Wuquan Wang, 13893208515
- Terminated
Lianyungang Maternal and Child Care Service Centre
Lianyungang, Jiangsu, 222002
- Recruiting
Liuzhou Maternal and Child Care Service Centre
Liuzhou, Guangxi, 545000
Wenhua Qin, 13768890218
- Terminated
Mianyang Central Hospital
Mianyang, Sichuan, 621000
- Recruiting
Nanjing Maternal and Child Care Service Centre
Nanjing, Jiangsu, 210000
Wenjian Xu, 13813829844
- Not yet recruiting
Fudan University affiliated Maternity Hospital
Shanghai, Shanghai Municipality, 200000
Guofu Zhang, 13916104313
- Recruiting
Hubei Maternal and Child Care Service Centre
Wuhan, Hubei, 430000
Weishun Lan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yanli Wang, 13838072509
About this study
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.
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.
- Conditions
- Infertility, Female
- Being tested
- ethiodized poppyseed oil, the second-generation non-ionic monomer contrast
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethiodized poppyseed oilDrug
Hysterosalpingography using ethiodized poppyseed oil
the second-generation non-ionic monomer contrastDrug
Hysterosalpingography using the second-generation non-ionic monomer contrast
| Study group | Role | What they receive |
|---|---|---|
| ethiodized poppyseed oil | Experimental | Not described Receives: Drug: ethiodized poppyseed oil |
| the second-generation non-ionic monomer contrast | Active comparator | Not described Receives: Drug: the second-generation non-ionic monomer contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging diagnostic quality of hysterosalpingography
defined as mean scores of 3 pictures shot at certain points
Measured: 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
Measured: 15 months （6 months for recruitment, 9 months for ongoing pregnancy）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start31 Jan 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing zhang, Guangzhou Women and Children's Medical Center
- Investigators
- Jing Zhang, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370575
- Sponsor's protocol ID
- 2017102708
- Status last verified
- Jul 2018
- First submitted
- 29 Nov 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 35399811
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03370575
- Acronym / sponsor ID
- 2017102708
- Conditions
- Infertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethiodized poppyseed oil | Experimental | Drug: ethiodized poppyseed oil |
| the second-generation non-ionic monomer contrast | Active comparator | Drug: the second-generation non-ionic monomer contrast |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethiodized poppyseed oilHysterosalpingography using ethiodized poppyseed oil | Drug | ethiodized poppyseed oil |
| the second-generation non-ionic monomer contrastHysterosalpingography using the second-generation non-ionic monomer contrast | Drug | the second-generation non-ionic monomer contrast |
Primary outcome
Imaging diagnostic quality of hysterosalpingography
Time frame: procedure (during hysterosalpingography)
defined as mean scores of 3 pictures shot at certain points
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Derived from this study: PubMed 35399811Zhang 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zhang principal investigator
Guangzhou Women and Children's Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ethiodized poppyseed oil and the second-generation non-ionic monomer contrast in people with Infertility, Female, run by Guangzhou Women and Children's Medical Center at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang (13828464628, fejr@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging diagnostic quality of hysterosalpingography (time frame: procedure (during hysterosalpingography)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.