InfertilityNCT01537276
Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
A study testing diagnose under real-time fluoroscopy in people with Infertility, run by YiYang Zhu at 1 site in China.
Trial summary
As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- diagnose under real-time fluoroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Nov 2011
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women seeking for a infertility laparoscopy
Who cannot join
- acute low reproductive duct infection
- a known hypersensitivity to iodine
- genital bleeding or malignancy
Trial locations and contacts
1 site in 1 country.
About this study
As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.
Read the detailed description
Tubal disease is responsible for 30-40% of female infertility in China. The lesions of fallopian tube include occlusion, hydrosalpinx, and adhesion. Many techniques were developed to assess the tubal pathology. Although laparoscopy can visualize the morphological abnormalities of fallopian tubes directly and is widely accepted as a gold standard for investigation of tubal patency, it is an invasive procedure and may carry of some risk. Hysterosalpingography, which uses contrast media and radiographic techniques to visualize the uterine cavity and tubal lumen, remains the first line screening since it was described by Carey.
As an essential step of the infertile work-up, HSG has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. Additional, HSG may have a potential therapeutic effect with the use of oil soluble contrast media for examination. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. In an early meta-analysis, HSG was regard as the limited use of evaluating the peritubal adhesions because of its low sensitivity. But in a recently small sample's report, the authors argued that the diagnostic accuracy of HSG in peritubal adhesion can be improved by analyzing some special signs on the radiographs.
Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.
- Conditions
- Infertility
- Being tested
- diagnose under real-time fluoroscopy
- Keywords
- hysterosalpingography, Fluoroscopy, diagnostic accuracy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnose under real-time fluoroscopyProcedure or surgery
Also called dynamic fluoroscopy
radiologists evaluating the tubal patency under fluoroscopy real-timely.Findings of fluoroscopy were blind to the investigators when the static radiographs were re-analyzed by the same team of radiologists.
| Study group | Role | What they receive |
|---|---|---|
| real-time fluoroscopy | Experimental | evaluating the tubal patency and pathology under fluoroscopy real-timely Receives: Procedure: diagnose under real-time fluoroscopy |
| respective image | No intervention | evaluating the tubal patency and pathology by Two supine and two oblique static images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal pathlogies. The pathlogies of tube is classified as the normal HSG, the proximal tubal obstruction, the hydrosalpinx (distal tubal obstruction), and the peritubal adhesions (at least one tube is patent) ,which is confirmed by laparoscopy in six month after HSG.
Measured: participants will be followed by laparoscopy in 6 month after HSG
Secondary outcomes (1)
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal patency. The patency of tube is classified as two-sided occlusion, one-sided occlusion and two side patency,which is confirmed by laparoscopy in six month after HSG.
Measured: participants will be followed by laparoscopy in 6 month after HSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- YiYang Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiYang Zhu, Taizhou Hospital
- Investigators
- Ying-Zi Mao, MD, Study director, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537276
- Sponsor's protocol ID
- taizhou201101
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
- ClinicalTrials.gov ID
- NCT01537276
- Acronym / sponsor ID
- taizhou201101
- Conditions
- Infertility
- Keywords
- hysterosalpingography, Fluoroscopy, diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- YiYang ZhuUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Feb 2012 (estimated)
- 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.
As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.
Detailed description
Tubal disease is responsible for 30-40% of female infertility in China. The lesions of fallopian tube include occlusion, hydrosalpinx, and adhesion. Many techniques were developed to assess the tubal pathology. Although laparoscopy can visualize the morphological abnormalities of fallopian tubes directly and is widely accepted as a gold standard for investigation of tubal patency, it is an invasive procedure and may carry of some risk. Hysterosalpingography, which uses contrast media and radiographic techniques to visualize the uterine cavity and tubal lumen, remains the first line screening since it was described by Carey.
As an essential step of the infertile work-up, HSG has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. Additional, HSG may have a potential therapeutic effect with the use of oil soluble contrast media for examination. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. In an early meta-analysis, HSG was regard as the limited use of evaluating the peritubal adhesions because of its low sensitivity. But in a recently small sample's report, the authors argued that the diagnostic accuracy of HSG in peritubal adhesion can be improved by analyzing some special signs on the radiographs.
Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-time fluoroscopy | Experimental | Procedure: diagnose under real-time fluoroscopyevaluating the tubal patency and pathology under fluoroscopy real-timely |
| respective image | No intervention | –evaluating the tubal patency and pathology by Two supine and two oblique static images. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women seeking for a infertility laparoscopy
Key exclusion criteria (3 listed)
- acute low reproductive duct infection
- a known hypersensitivity to iodine
- genital bleeding or malignancy
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 |
|---|---|---|
| diagnose under real-time fluoroscopyAlso: dynamic fluoroscopyradiologists evaluating the tubal patency under fluoroscopy real-timely.Findings of fluoroscopy were blind to the investigators when the static radiographs were re-analyzed by the same team of radiologists. | Procedure or surgery | real-time fluoroscopy |
Primary outcome
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies
Time frame: participants will be followed by laparoscopy in 6 month after HSG
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal pathlogies. The pathlogies of tube is classified as the normal HSG, the proximal tubal obstruction, the hydrosalpinx (distal tubal obstruction), and the peritubal adhesions (at least one tube is patent) ,which is confirmed by laparoscopy in six month after HSG.
1 secondary outcome
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency
Time frame: participants will be followed by laparoscopy in 6 month after HSG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
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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.
Ying-Zi Mao, MD study director
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical 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 diagnose under real-time fluoroscopy in people with Infertility, run by YiYang Zhu 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies (time frame: participants will be followed by laparoscopy in 6 month after HSG). 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 23 Feb 2012.