PainPhase 2NCT02823119
Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Office Hysteroscopy
A Phase 2 study testing Mini-hysteroscopy and Conventional Office Hysteroscopy in people with Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Mini-hysteroscopy and Conventional Office Hysteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Jun 2017
- Phase
- Phase 2
- 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
- Nulliparous patients
Who cannot join
- Parous patients, menopausal status, cervical pathology, and previous cervical surgery
Trial locations and contacts
1 site in 1 country.
Usama M Fouda, M.D, PhD contact
About this study
Official title: Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial
The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Read the detailed description
The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
- Conditions
- Pain
- Being tested
- Mini-hysteroscopy, Conventional Office Hysteroscopy
- Keywords
- Mini-hysteroscopy, Office hysteroscopy, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-hysteroscopyDevice
Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic.
Conventional Office HysteroscopyDevice
. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic.
| Study group | Role | What they receive |
|---|---|---|
| Mini-hysteroscopy | Experimental | A rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. Receives: Device: Mini-hysteroscopy |
| Conventional Office Hysteroscopy | Active comparator | A rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm Receives: Device: Conventional Office Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Intensity of pain assessed by the Visual Analog Scale (VAS)"
Measured: up to 30 minutes
Secondary outcomes (1)
Duration of procedure
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usama M Fouda, Cairo University
- Investigators
- Usama M Fouda, M.D, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823119
- Sponsor's protocol ID
- Hysteroscope size & pain
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7- and 4-mm hysteroscopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med. 2005 Jan;50(1):45-8.
PubMed 15730173
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02823119
- Acronym / sponsor ID
- Hysteroscope size & pain
- Conditions
- Pain
- Keywords
- Mini-hysteroscopy, Office hysteroscopy, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 6 Jul 2016 (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 evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Detailed description
The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-hysteroscopy | Experimental | Device: Mini-hysteroscopyA rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. |
| Conventional Office Hysteroscopy | Active comparator | Device: Conventional Office HysteroscopyA rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nulliparous patients
Key exclusion criteria (1 listed)
- Parous patients, menopausal status, cervical pathology, and previous cervical surgery
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 |
|---|---|---|
| Mini-hysteroscopyHysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic. | Device | Mini-hysteroscopy |
| Conventional Office Hysteroscopy. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic. | Device | Conventional Office Hysteroscopy |
Primary outcome
Intensity of pain
Time frame: up to 30 minutes
Intensity of pain assessed by the Visual Analog Scale (VAS)"
1 secondary outcome
Duration of procedure
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Background: PubMed 15730173Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7- and 4-mm hysteroscopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med. 2005 Jan;50(1):45-8.
- Individual participant dataSharing planned: Undecided
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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.
Usama M Fouda, M.D, PhD contact
Usama M Fouda, M.D, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mini-hysteroscopy and Conventional Office Hysteroscopy in people with Pain, run by Cairo University at 1 site in Egypt.
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 1 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 6 Jul 2016. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Usama M Fouda, M.D, PhD (umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823119, which also lists 1 linked publication.
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 Jul 2016.