InfertilityNCT00956774
Comparison of Three Cannulas for Hysterosalpingography
A study testing HSG with acorn-tipped cannula, HSG with cervical vacuum cup and HSG with balloon catheter in people with Infertility, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- HSG with acorn-tipped cannula, HSG with cervical vacuum cup and HSG with balloon catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing HSG at an academic medical center
Who cannot join
- Contrast media allergy
- Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
- Contraindication to NSAID use
- Known active pelvic infection
- Active vaginal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.
Read the detailed description
This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias.
Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.
- Conditions
- Infertility
- Being tested
- HSG with acorn-tipped cannula, HSG with cervical vacuum cup, HSG with balloon catheter
- Keywords
- HSG, Cannula, HSG procedure, infertility evaluation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSG with acorn-tipped cannulaProcedure or surgery
Use of acorn-tipped cannula for HSG to evaluate tubal patency
HSG with cervical vacuum cupProcedure or surgery
cup placed over cervix to create vacuum pressure.
HSG with balloon catheterProcedure or surgery
balloon inserted via catheter into cervic for dilation.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Catheter | Active comparator | Not described Receives: Procedure: HSG with balloon catheter |
| Cervical Vacuum Cup | Active comparator | Not described Receives: Procedure: HSG with cervical vacuum cup |
| acorn-tipped cannula | Active comparator | Not described Receives: Procedure: HSG with acorn-tipped cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
Measured: 15 minutes
Secondary outcomes (4)
the total duration of the procedure
Measured: 15 minutes
direct fluoroscopic time
Measured: 15 minutes
rates of vasovagal reaction
Measured: 15 minutes
diagnostic quality of images obtained
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Lane, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956774
- Sponsor's protocol ID
- Comparison of 3 Cannulas - HSG
- Status last verified
- Feb 2013
- First submitted
- 10 Aug 2009
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00956774
- Acronym / sponsor ID
- Comparison of 3 Cannulas - HSG
- Conditions
- Infertility
- Keywords
- HSG, Cannula, HSG procedure, infertility evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Aug 2009 (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.
The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.
Detailed description
This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias.
Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Balloon Catheter | Active comparator | Procedure: HSG with balloon catheter |
| Cervical Vacuum Cup | Active comparator | Procedure: HSG with cervical vacuum cup |
| acorn-tipped cannula | Active comparator | Procedure: HSG with acorn-tipped cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing HSG at an academic medical center
Key exclusion criteria (5 listed)
- Contrast media allergy
- Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
- Contraindication to NSAID use
- Known active pelvic infection
- Active vaginal bleeding
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 |
|---|---|---|
| HSG with acorn-tipped cannulaUse of acorn-tipped cannula for HSG to evaluate tubal patency | Procedure or surgery | acorn-tipped cannula |
| HSG with cervical vacuum cupcup placed over cervix to create vacuum pressure. | Procedure or surgery | Cervical Vacuum Cup |
| HSG with balloon catheterballoon inserted via catheter into cervic for dilation. | Procedure or surgery | Balloon Catheter |
Primary outcome
pain scores
Time frame: 15 minutes
4 secondary outcomes
the total duration of the procedure
Time frame: 15 minutes
direct fluoroscopic time
Time frame: 15 minutes
rates of vasovagal reaction
Time frame: 15 minutes
diagnostic quality of images obtained
Time frame: 1 month
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 25 Apr 2022.
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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.
Sara Lane, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSG with acorn-tipped cannula, HSG with cervical vacuum cup and HSG with balloon catheter in people with Infertility, run by Wake Forest University Health Sciences at 1 site in United States.
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 5 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 25 Apr 2022. 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 United States. 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?
pain scores (time frame: 15 minutes). 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 25 Apr 2022.