Leiomyoma of UterusNCT04373694
Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
A study testing vaginoscopy and standard hysteroscopy in people with Leiomyoma of Uterus, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma of Uterus
- What is being tested?
- vaginoscopy and standard hysteroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2020to 31 Dec 2024
- 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 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- polyp or fibroid previously diagnosed by hysteroscopy
- polyp less than 2 cm
- submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
- if more than 1 fibroid: total fibroid have to be less or equal 4 cm
Who cannot join
- cervical stenosis
- polyp or fibroid more than 2 cm
- pregnancy
- blood dyscrasia
Trial locations and contacts
1 site in 1 country.
Canada1 site
CHUM - Clinique Médecine et biologie de la reproduction
Montreal, Quebec, H2X 1P1
About this study
Official title: Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.
Read the detailed description
78 participants will be randomised in two groups:
- traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.
- Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution
In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy
- Conditions
- Leiomyoma of Uterus
- Being tested
- vaginoscopy, standard hysteroscopy
- Keywords
- vaginoscopy, hysteroscopy morcellation, infertile population
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginoscopyProcedure or surgery
vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
standard hysteroscopyProcedure or surgery
speculum, paracervical block before hysteroscopy morcellation
| Study group | Role | What they receive |
|---|---|---|
| Standard hysteroscopy | Active comparator | morcellation hysteroscopy with intravenous sedation and paracervical bloc Receives: Procedure: standard hysteroscopy |
| Vaginoscopy | Experimental | morcellation hysteroscopy with only intravenous sedation Receives: Procedure: vaginoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain
Measured: immediately after intervention
Secondary outcomes (5)
Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
length of time in minutes between start and end of procedure including morcellation
Measured: immediately after intervention
Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group
Presence of jerky abnormal movements or a slow weak pulse rate associated to at least one symptoms: nausea, pale skin, blurred vision, warm feeling or cold sweat.
Measured: immediately after surgery
Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group
presence of one or more signs during intervention: extension of the instrument goes beyong the limitation of the uterus, loss of resistance, sudden loss of vision, direct visualisation of the perforation
Measured: immediatly after surgery
Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group
length of time in months to continue fertility treatment after procedure
Measured: up to 1 year
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
length of time in months to be pregnant after procedure
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start9 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma of UterusStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- Carole KAMGA-NGANDE, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373694
- Sponsor's protocol ID
- 19.380
- Status last verified
- Jan 2023
- First submitted
- 23 Apr 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04373694
- Acronym / sponsor ID
- 19.380
- Conditions
- Leiomyoma of Uterus
- Keywords
- vaginoscopy, hysteroscopy morcellation, infertile population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 May 2020 (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.
This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.
Detailed description
78 participants will be randomised in two groups:
- traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.
- Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution
In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hysteroscopy | Active comparator | Procedure: standard hysteroscopymorcellation hysteroscopy with intravenous sedation and paracervical bloc |
| Vaginoscopy | Experimental | Procedure: vaginoscopymorcellation hysteroscopy with only intravenous sedation |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- polyp or fibroid previously diagnosed by hysteroscopy
- polyp less than 2 cm
- submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
- if more than 1 fibroid: total fibroid have to be less or equal 4 cm
Key exclusion criteria (4 listed)
- cervical stenosis
- polyp or fibroid more than 2 cm
- pregnancy
- blood dyscrasia
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 |
|---|---|---|
| vaginoscopyvaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps) | Procedure or surgery | Vaginoscopy |
| standard hysteroscopyspeculum, paracervical block before hysteroscopy morcellation | Procedure or surgery | Standard hysteroscopy |
Primary outcome
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
Time frame: immediately after intervention
10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain
5 secondary outcomes
Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
Time frame: immediately after intervention
Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group
Time frame: immediately after surgery
Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group
Time frame: immediatly after surgery
Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group
Time frame: up to 1 year
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Carole KAMGA-NGANDE, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginoscopy and standard hysteroscopy in people with Leiomyoma of Uterus, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. 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 Canada. 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?
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?
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group (time frame: immediately after intervention). 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 12 Jan 2023.