Gynecologic DiseaseNCT03135353
Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding
A study testing 3D saline infusion sonohysterography and Office Hysteroscopy in people with Gynecologic Disease, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- 3D saline infusion sonohysterography and Office Hysteroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2017to 30 Nov 2018
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female aged between 20 and 45 years
- with no medical disorders
- approving to participate in the study
Who cannot join
- vaginal or cervical lesions
- history or suspicion of PID
- IUD users
- bleeding disorders
- on anticoagulant therapy
- irregular use of oral contraceptive pills
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el ainy hospital
Cairo, 12211
Dina M Dakhly, M.D., 01003498919 ext. +2, Dinadakhly@mail.com
Dina M Dakhly, M.D.
About this study
Official title: Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age
- Conditions
- Gynecologic Disease
- Being tested
- 3D saline infusion sonohysterography, Office Hysteroscopy
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D saline infusion sonohysterographyDevice
instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae
Office HysteroscopyDevice
an outpatient procedure done to assess the uterine cavity using the office hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| 3D saline infusion sonohysterography | Experimental | participants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography Receives: Device: 3D saline infusion sonohysterography |
| Office hysteroscopy | Experimental | after undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS Receives: Device: Office Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start20 Apr 2017
- Primary completion25 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135353
- Sponsor's protocol ID
- ED200417
- Status last verified
- Oct 2018
- First submitted
- 20 Apr 2017
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
- ClinicalTrials.gov ID
- NCT03135353
- Acronym / sponsor ID
- ED200417
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 25 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 1 May 2017 (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.
comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D saline infusion sonohysterography | Experimental | Device: 3D saline infusion sonohysterographyparticipants presenting with abnormal uterine bleeding will undergo 3D saline infusion sonohysterography |
| Office hysteroscopy | Experimental | Device: Office Hysteroscopyafter undergoing 3D SIS, cases would undergo office hysteroscopy and the investigator would be blinded to the results of SIS |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female aged between 20 and 45 years
- with no medical disorders
- approving to participate in the study
Key exclusion criteria (6 listed)
- vaginal or cervical lesions
- history or suspicion of PID
- IUD users
- bleeding disorders
- on anticoagulant therapy
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 |
|---|---|---|
| 3D saline infusion sonohysterographyinstillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae | Device | 3D saline infusion sonohysterography |
| Office Hysteroscopyan outpatient procedure done to assess the uterine cavity using the office hysteroscopy | Device | Office hysteroscopy |
Primary outcome
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
Time frame: 6 months
The results of the two procedures would be compared with the operative findings and later histopathological assessment of the specimens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Dina MR Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D saline infusion sonohysterography and Office Hysteroscopy in people with Gynecologic Disease, run by Woman's Health University Hospital, Egypt 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 3 inclusion and 6 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 23 Oct 2018. 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.
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 Dina MR Dakhly, MD (01003498919 ext. 002, dinadakhly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB (time frame: 6 months). 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 23 Oct 2018.