InfertilityPhase 4NCT01936116
Optimal Balloon Catheter Placement During Sonohysterography
A Phase 4 study testing sonohysterography with inflated catheter in uterine cavity and sonohysterography with inflated catheter in cervical cavity in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- sonohysterography with inflated catheter in uterine cavity and sonohysterography with inflated catheter in cervical cavity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Oct 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile patients who will be referred to Royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired \& congenital abnormalities) are included in this prospective comparative study.
Who cannot join
- Symptoms of active pelvic infection
- Abnormal uterine bleeding
- Women with cervical stenosis
- Women with each lesions which disrupts catheterization such as large myoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Perception and Side Effects During Sonohysterography With Balloon Catheters: a Randomized Comparative Study of Cervical With Uterine Catheter Placement
Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. The purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.
Read the detailed description
The proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. A total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. The examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. Patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed based on the intent-to-treat principle.
- Conditions
- Infertility
- Being tested
- sonohysterography with inflated catheter in uterine cavity, sonohysterography with inflated catheter in cervical cavity
- Keywords
- Sonohysterography, catheter placement, pain magnitude, vasovagal reaction
- Medical subject headings
- Infertility, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonohysterography with inflated catheter in uterine cavityDevice
during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity
sonohysterography with inflated catheter in cervical cavityDevice
During the procedure of sonohysterography balloon catheter is inflated in the cervical canal
| Study group | Role | What they receive |
|---|---|---|
| patients with intrauterine balloon catheter placement | Experimental | In this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity Receives: Device: sonohysterography with inflated catheter in uterine cavity |
| patients with intracervical balloon catheter placement | Active comparator | During the procedure of sonohysterography balloon catheter is inflated in the cervical canal Receives: Device: sonohysterography with inflated catheter in cervical cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
perceived Pain
inflation of the balloon \& deflation of the balloon by a 10-point visual analog pain scale
Measured: during sonohysterography
Vasovagal reactions
Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure .
Measured: During sonohysterography
vasovagal reaction
Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure .
Measured: 30 minutes after sonohysterography
Secondary outcomes (2)
Saline volume
Evaluation the saline volume that is required for sonohisterography
Measured: during sonohysterography
time of procedure
Evaluation the total time that is needed for sonohysterography.
Measured: during sonohysterography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionOct 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteFatemeh Zafarani, MSc, Study director, Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive BiomedicineFiroozeh Ahmadi, MD, Principal investigator, Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936116
- Sponsor's protocol ID
- Royan-Emb-016
- Status last verified
- Feb 2012
- First submitted
- 25 Aug 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception and Side Effects During Sonohysterography With Balloon Catheters: a Randomized Comparative Study of Cervical With Uterine Catheter Placement
- ClinicalTrials.gov ID
- NCT01936116
- Acronym / sponsor ID
- Royan-Emb-016
- Conditions
- Infertility
- Keywords
- Sonohysterography, catheter placement, pain magnitude, vasovagal reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Sep 2013 (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.
Saline infusion sonohysterography and other intrauterine investigations methods may cause uterine cramping, pain and vasovagal reactions. According to few of previous studies the position of catheter placement can affect the magnitude of pain and amount of saline required during the sonohysterography. The purpose of this double blind control trial study is to assess whether the location of the balloon catheter either the uterus or cervix during sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.
Detailed description
The proposal of study approved by the investigators institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. A total of 300 infertile women undergoing sonohysterography will be randomized to intrauterine or intracervical balloon catheter placement. The examination is scheduled in the early follicular phase of menstrual cycle, immediately after cessation of menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible catheter is introduced into the cervical canal and balloon at the catheter tip is placed in the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is slowly introduced into the cavity until an adequate distention of the uterine cavity is obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to assess their level of pain at the time of the balloon inflation and deflation using a 10-point visual analog pain scale. Patients are checked for the sign and symptoms of vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed based on the intent-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with intrauterine balloon catheter placement | Experimental | Device: sonohysterography with inflated catheter in uterine cavityIn this group, during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity |
| patients with intracervical balloon catheter placement | Active comparator | Device: sonohysterography with inflated catheter in cervical cavityDuring the procedure of sonohysterography balloon catheter is inflated in the cervical canal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile patients who will be referred to Royan institute for sonohysterography to evaluate the internal structure of uterine cavity (acquired \& congenital abnormalities) are included in this prospective comparative study.
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| sonohysterography with inflated catheter in uterine cavityduring the procedure of sonohysterography balloon catheter is inflated in the uterine cavity | Device | patients with intrauterine balloon catheter placement |
| sonohysterography with inflated catheter in cervical cavityDuring the procedure of sonohysterography balloon catheter is inflated in the cervical canal | Device | patients with intracervical balloon catheter placement |
Primary outcome
perceived Pain
Time frame: during sonohysterography
inflation of the balloon \& deflation of the balloon by a 10-point visual analog pain scale
Vasovagal reactions
Time frame: During sonohysterography
Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients During procedure .
vasovagal reaction
Time frame: 30 minutes after sonohysterography
Evaluation the vasovagal reactions (Hypotension, vomiting, syncope)in patients 30 minutes after procedure .
2 secondary outcomes
Saline volume
Time frame: during sonohysterography
time of procedure
Time frame: during sonohysterography
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 6 May 2014.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Fatemeh Zafarani, MSc study director
Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
Firoozeh Ahmadi, MD principal investigator
Department of Reproductive Imaging at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sonohysterography with inflated catheter in uterine cavity and sonohysterography with inflated catheter in cervical cavity in people with Infertility, run by Royan Institute at 1 site in Iran.
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 6 May 2014. 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 Iran. 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?
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?
perceived Pain (time frame: during sonohysterography). The study lists 3 primary outcomes in all. 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 6 May 2014.