HysteroscopyNCT06637111
Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.
A study testing Ultrasound guided office hysteroscopy group and Conventional office hysteroscopy group in people with Hysteroscopy, run by Cairo University at 2 sites in Egypt.
Trial summary
The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Ultrasound guided office hysteroscopy group and Conventional office hysteroscopy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of failure of office hysteroscopy
Who cannot join
- Pelvic inflammatory disease
- Severe vaginal bleeding
- Pregnancy
- Allergy to lidocaine, prilocaine or diclofenac potassium
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of medicine, Cairo university
Cairo
Usama M Fouda, Prof., umfrfouda@kasralainy.edu.eg
- Recruiting
Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Cairo
Usama M Fouda, Prof, 01095401375, umfrfouda@kasralainy.edu.eg
Usama M Fouda, Prof
About this study
Official title: Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.A Randomized Controlled Study
The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.
- Conditions
- Hysteroscopy
- Being tested
- Ultrasound guided office hysteroscopy group, Conventional office hysteroscopy group
- Keywords
- Hysteroscopy, Ultrasound, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided office hysteroscopy groupProcedure or surgery
One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem. The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal.
All procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.
A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.
Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity
Conventional office hysteroscopy groupProcedure or surgery
One hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem . The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal.
All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.
A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided office hysteroscopy group | Active comparator | All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.
A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia.
Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity Receives: Procedure: Ultrasound guided office hysteroscopy group |
| Conventional office hysteroscopy group | Active comparator | All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures.
A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. Receives: Procedure: Conventional office hysteroscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]
Percentage of successfully performed office hysteroscopy [ = number of successful office hysteroscopies /total number of office hysteroscopies]
Measured: Immediately after the procedure
Secondary outcomes (1)
Intensity of pain
Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (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 HysteroscopyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Bedaya Hospital
- Responsible party
- Principal investigator, Usama M Fouda, Cairo University
- Investigators
- Usama M Fouda, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637111
- Sponsor's protocol ID
- Ultrasonography/hysteroscopy
- Status last verified
- Apr 2025
- First submitted
- 9 Oct 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kresowik JD, Syrop CH, Van Voorhis BJ, Ryan GL. Ultrasound is the optimal choice for guidance in difficult hysteroscopy. Ultrasound Obstet Gynecol. 2012 Jun;39(6):715-8. doi: 10.1002/uog.11072.
PubMed 22173892
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06637111
- Acronym / sponsor ID
- Ultrasonography/hysteroscopy
- Conditions
- Hysteroscopy
- Keywords
- Hysteroscopy, Ultrasound, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Bedaya Hospital
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided office hysteroscopy group | Active comparator | Procedure: Ultrasound guided office hysteroscopy groupAll the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity |
| Conventional office hysteroscopy group | Active comparator | Procedure: Conventional office hysteroscopy groupAll the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with history of failure of office hysteroscopy
Key exclusion criteria (4 listed)
- Pelvic inflammatory disease
- Severe vaginal bleeding
- Pregnancy
- Allergy to lidocaine, prilocaine or diclofenac potassium
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 |
|---|---|---|
| Ultrasound guided office hysteroscopy groupOne hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem. The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal. All procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. Transabdominal ultrasound will be used to guide the access of the hysteroscope to the uterine cavity | Procedure or surgery | Ultrasound guided office hysteroscopy group |
| Conventional office hysteroscopy groupOne hour before office hysteroscopy, 100 mg of diclofenac potassium will be administered per orem . The patients will be asked to drink about one liter of water and to avoid urination before the procedure Moreover, a few minutes prior to the office hysteroscopy, 3 ml of 5% lidocaine and prilocaine topical cream will be introduced into the endocervical canal. All the procedures will be performed using the vaginoscopic technique. A rigid 2.9-mm hysteroscope with a 30° lens and a 5-mm outer sheath (Karl Storz GmbH, Tuttlingen, Germany) will be used in all procedures. A 5 Fr grasper and 5 Fr scissors will be used to widen the stenotic internal or external ostia. | Procedure or surgery | Conventional office hysteroscopy group |
Primary outcome
Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]
Time frame: Immediately after the procedure
Percentage of successfully performed office hysteroscopy [ = number of successful office hysteroscopies /total number of office hysteroscopies]
1 secondary outcome
Intensity of pain
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 22173892Kresowik JD, Syrop CH, Van Voorhis BJ, Ryan GL. Ultrasound is the optimal choice for guidance in difficult hysteroscopy. Ultrasound Obstet Gynecol. 2012 Jun;39(6):715-8. doi: 10.1002/uog.11072.
- Individual participant dataSharing planned: No
Related trials for Hysteroscopy
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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.
Usama M Fouda principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided office hysteroscopy group and Conventional office hysteroscopy group in people with Hysteroscopy, run by Cairo University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Usama M Fouda, Prof. (01095401375 ext. +2, umfrfouda@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity] (time frame: Immediately after the procedure). 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 NCT06637111, 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 30 Apr 2025.