InfertilityNCT04744610
Self-controlled Study Between 4-hour and 24-hour Delayed Radiographs in HSG Using OSCM
A study testing Add 4-hour delayed radiographs in people with Infertility, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Background of the study: Hysterosalpingography (HSG) is widely used for the female infertility workup. Many studies have demonstrated that the use of oil-soluble contrast medium (OSCM) ethiodized oil for HSG surgery can improve pregnancy rates. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Add 4-hour delayed radiographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2020to Mar 2021
- Phase
- Interventional
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having spontaneous ovulation or inducing ovulation;
- Infertility lasting for 12 months;
- Conforms to the indications of hysterosalpingography;
- Understand and sign the informed consent;
Who cannot join
- Iodine allergy or hyperthyroidism
- Acute genital tract inflammation or abnormal leucorrhea examination;
- Abnormal vaginal bleeding;
- Fever or preoperative temperature higher than 37.5℃ within 3 days before angiography;
- Severe insufficiency of cardiopulmonary or liver function;
- During pregnancy and menstruation;
- With complications that may cause subjects to be unable to follow the study plan or even endanger the patient's safety or social environment;
- Patients who are participating in other clinical studies or who are not suitable for inclusion in this study due to other reasons considered by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Yimin Zhu, 057189992071, zhuyim@zju.edu.cn
About this study
Official title: Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography
Background of the study:
Hysterosalpingography (HSG) is widely used for the female infertility workup. Many studies have demonstrated that the use of oil-soluble contrast medium (OSCM) ethiodized oil for HSG surgery can improve pregnancy rates. However,The 24-hour delayed radiographs of OSCM HSG also brought some inconvenience to the patients , for example, patients need to make two trips to the hospital.
Read more
Objective of the study:
The purpose of this study was to compare OSCM HSGs using 4-hour and 24-hour delayed radiographs in terms of diagnosing tubal patency and identifying the presence of pelvic adhesions.
Study design:
Prospective, open label, self - controlled study
Study population:
Infertile patients scheduled for an OSCM HSG
- Conditions
- Infertility
- Being tested
- Add 4-hour delayed radiographs
- Keywords
- Infertility, Hysterosalpingography, Oil-soluble contrast medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Add 4-hour delayed radiographsDiagnostic test
Normal patients only need to take delayed radiographs 24h after HSG operation. In this study, 4-hour delayed radiographs were added to the 24-hour delayed radiographs, so that the patients had to take one more delayed radiographs .
| Study group | Role | What they receive |
|---|---|---|
| 4-hour delayed radiographs | Other | The follow-up radiographs was taken 4 h after the HSG operation. Receives: Diagnostic Test: Add 4-hour delayed radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion.
The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
Measured: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Secondary outcomes (3)
Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion.
The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
Measured: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion.
The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
Measured: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs.
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion.
The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
Measured: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start22 Oct 2020
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yimin Zhu, Study chair, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744610
- Sponsor's protocol ID
- IRB-20200261-R
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography
- ClinicalTrials.gov ID
- NCT04744610
- Acronym / sponsor ID
- IRB-20200261-R
- Conditions
- Infertility
- Keywords
- Infertility, Hysterosalpingography, Oil-soluble contrast medium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 9 Feb 2021 (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.
Background of the study:
Hysterosalpingography (HSG) is widely used for the female infertility workup. Many studies have demonstrated that the use of oil-soluble contrast medium (OSCM) ethiodized oil for HSG surgery can improve pregnancy rates. However,The 24-hour delayed radiographs of OSCM HSG also brought some inconvenience to the patients , for example, patients need to make two trips to the hospital.
Objective of the study:
The purpose of this study was to compare OSCM HSGs using 4-hour and 24-hour delayed radiographs in terms of diagnosing tubal patency and identifying the presence of pelvic adhesions.
Study design:
Prospective, open label, self - controlled study
Study population:
Infertile patients scheduled for an OSCM HSG
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-hour delayed radiographs | Other | Diagnostic Test: Add 4-hour delayed radiographsThe follow-up radiographs was taken 4 h after the HSG operation. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having spontaneous ovulation or inducing ovulation;
- Infertility lasting for 12 months;
- Conforms to the indications of hysterosalpingography;
- Understand and sign the informed consent;
Key exclusion criteria (8 listed)
- Iodine allergy or hyperthyroidism
- Acute genital tract inflammation or abnormal leucorrhea examination;
- Abnormal vaginal bleeding;
- Fever or preoperative temperature higher than 37.5℃ within 3 days before angiography;
- Severe insufficiency of cardiopulmonary or liver function;
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 |
|---|---|---|
| Add 4-hour delayed radiographsNormal patients only need to take delayed radiographs 24h after HSG operation. In this study, 4-hour delayed radiographs were added to the 24-hour delayed radiographs, so that the patients had to take one more delayed radiographs . | Diagnostic test | 4-hour delayed radiographs |
Primary outcome
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
Time frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different.
3 secondary outcomes
Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
Time frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs
Time frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs.
Time frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Yimin Zhu study chair
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Add 4-hour delayed radiographs in people with Infertility, run by Women's Hospital School Of Medicine Zhejiang University at 1 site 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 4 inclusion and 8 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Yimin Zhu (057189992071, zhuyim@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs. (time frame: The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.