Fallopian Tube OcclusionNCT03116867
Sonosalpingography After Hysteroscopic Tubal Occlusion
An observational study of Fallopian Tube Occlusion, run by Ain Shams University at 1 site in Egypt.
Trial summary
Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fallopian Tube Occlusion
- What is being tested?
- sonosalpingography
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- May 2017to Apr 2018
- Phase
- Observational
- 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 40 years
- Women only
- Adult
Study population: patients requiring tubal occlusion
Who may be able to join
- Infertile patients with hydrosalpinges requiring in vitro fertilization
- irreversible contraception
Who cannot join
- Acute pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo
Sherif H Hussain, MD
About this study
Official title: Sonosalpingography in Assessment of Efficacy of Hysteroscopic Tubal Occlusion by Roller Ball Electrode
Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode.
- Conditions
- Fallopian Tube Occlusion
- Being tested
- sonosalpingography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonosalpingographyOther
transvaginal ultrasound with saline infusion
| Study group | Role | What they receive |
|---|---|---|
| patients receiving hysteroscopic tubal occlusion | This group will have sonosalpingography done for them one month after the tubal occlusion. Receives: Other: sonosalpingography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of fluid in douglas pouch detected by transvaginal ultrasound after saline infusion through the cervix
after saline infusion is done, presence of fluid in douglas pouch means that hysteroscopic occlusion of tubes was not successful.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube OcclusionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Hanafi Hussain, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116867
- Sponsor's protocol ID
- Ainshams528
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 17 Apr 2017
- 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 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonosalpingography in Assessment of Efficacy of Hysteroscopic Tubal Occlusion by Roller Ball Electrode
- ClinicalTrials.gov ID
- NCT03116867
- Acronym / sponsor ID
- Ainshams528
- Conditions
- Fallopian Tube Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 17 Apr 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.
Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving hysteroscopic tubal occlusion | – | Other: sonosalpingographyThis group will have sonosalpingography done for them one month after the tubal occlusion. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- patients requiring tubal occlusion
Key inclusion criteria (2 listed)
- Infertile patients with hydrosalpinges requiring in vitro fertilization
- irreversible contraception
Key exclusion criteria (1 listed)
- Acute pelvic inflammatory disease
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 |
|---|---|---|
| sonosalpingographytransvaginal ultrasound with saline infusion | Other | patients receiving hysteroscopic tubal occlusion |
Primary outcome
The presence of fluid in douglas pouch detected by transvaginal ultrasound after saline infusion through the cervix
Time frame: immediate
after saline infusion is done, presence of fluid in douglas pouch means that hysteroscopic occlusion of tubes was not successful.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Individual participant dataSharing planned: No
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Laser, Acupoints
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Occlusion, run by Ain Shams 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 2 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 17 Apr 2017. 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 Sherif H Hussain, MD (0201005219239, docsherif77@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of fluid in douglas pouch detected by transvaginal ultrasound after saline infusion through the cervix (time frame: immediate). 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 17 Apr 2017.