InfertilityNCT00870935
A Trial to Compare Three Methods of Performing Hysterosalpingography
A study testing Balloon catheter and Cervical vacuum cup in people with Infertility, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
The purpose of this study is: to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate; to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Balloon catheter and Cervical vacuum cup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2007to Sep 2009
- 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 25 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility
Who cannot join
- hypersensitivity to iodine or radio-opaque contrast dye
- cervicitis
- genital bleeding
- genital malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
The purpose of this study is:
- to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate;
- to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.
Read the detailed description
A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice").
The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10.
A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered.
At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.
- Conditions
- Infertility
- Being tested
- Balloon catheter, Cervical vacuum cup
- Keywords
- Balloon catheter, Cervical vacuum cup, Hysterosalpingography, Infertility, Pain, Fallopian Tube Patency Tests, Female Infertility
- Medical subject headings
- Infertility, Pain, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon catheterProcedure or surgery
Hysterosalpingography is performed using intrauterine balloon catheter
Cervical vacuum cupProcedure or surgery
Hysterosalpingography is performed using cervical vacuum cup
| Study group | Role | What they receive |
|---|---|---|
| Balloon catheter | Active comparator | Hysterosalpingography using intrauterine Balloon catheter Receives: Procedure: Balloon catheter |
| Cervical vacuum cup | Active comparator | Hysterosalpingography using cervical vacuum cup Receives: Procedure: Cervical vacuum cup |
| Operator choice | Experimental | Hysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice Receives: Procedure: Balloon catheter; Procedure: Cervical vacuum cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate to complete hysterosalpingography (HSG)
Measured: two years
Secondary outcomes (11)
the objective difficulty to perform HSG
Measured: two years
the subjective difficulty to perform HSG
Measured: two years
the fluoroscopic time
Measured: two years
the length of the procedure of device application
Measured: two years
the volume of contrast medium used
Measured: two years
gynecologist satisfaction with the procedure
Measured: two years
radiologist satisfaction with the procedure
Measured: two years
the percentage of short-term complications
Measured: two years
the percentage of long-term complications
Measured: two years
correlation between patient medical history and the degree of pain experienced during the HSG procedure
Measured: two years
the degree of pain experienced during the HSG procedure
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionSep 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Ricci, MD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870935
- Sponsor's protocol ID
- RU02/07
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study to Compare the Efficacy and the Tolerability of Three Methods of Performing Hysterosalpingography
- ClinicalTrials.gov ID
- NCT00870935
- Acronym / sponsor ID
- RU02/07
- Conditions
- Infertility
- Keywords
- Balloon catheter, Cervical vacuum cup, Hysterosalpingography, Infertility, Pain, Fallopian Tube Patency Tests, Female Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Mar 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 purpose of this study is:
- to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate;
- to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.
Detailed description
A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice").
The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10.
A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered.
At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Balloon catheter | Active comparator | Procedure: Balloon catheterHysterosalpingography using intrauterine Balloon catheter |
| Cervical vacuum cup | Active comparator | Procedure: Cervical vacuum cupHysterosalpingography using cervical vacuum cup |
| Operator choice | Experimental | Procedure: Balloon catheter, Procedure: Cervical vacuum cupHysterosalpingography is performed using either balloon catheter or cervical vacuum cup on the basis of the operator's choice |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertility
Key exclusion criteria (4 listed)
- hypersensitivity to iodine or radio-opaque contrast dye
- cervicitis
- genital bleeding
- genital 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 |
|---|---|---|
| Balloon catheterHysterosalpingography is performed using intrauterine balloon catheter | Procedure or surgery | Balloon catheter, Operator choice |
| Cervical vacuum cupHysterosalpingography is performed using cervical vacuum cup | Procedure or surgery | Cervical vacuum cup, Operator choice |
Primary outcome
failure rate to complete hysterosalpingography (HSG)
Time frame: two years
11 secondary outcomes
the objective difficulty to perform HSG
Time frame: two years
the subjective difficulty to perform HSG
Time frame: two years
the fluoroscopic time
Time frame: two years
the length of the procedure of device application
Time frame: two years
the volume of contrast medium used
Time frame: two years
gynecologist satisfaction with the procedure
Time frame: two years
radiologist satisfaction with the procedure
Time frame: two years
the percentage of short-term complications
Time frame: two years
the percentage of long-term complications
Time frame: two years
correlation between patient medical history and the degree of pain experienced during the HSG procedure
Time frame: two years
the degree of pain experienced during the HSG procedure
Time frame: two years
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 3 Dec 2010.
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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.
Giuseppe Ricci, MD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon catheter and Cervical vacuum cup in people with Infertility, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 4 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 3 Dec 2010. 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 Italy. 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?
failure rate to complete hysterosalpingography (HSG) (time frame: two years). 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 3 Dec 2010.