Tubal PatencyNCT03953586
Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
An observational study of Tubal Patency, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Tubal Patency
- What is being tested?
- Bubble suction test and tubal peristalsis
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2019to 20 Aug 2020
- 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
- No healthy volunteers
- Adult
Study population: Infertile women with a history of HSG
Who may be able to join
- Infertility patients scheduled for combined laparoscopy and hysteroscopy
Who cannot join
- No HSG
Trial locations and contacts
1 site in 1 country.
About this study
Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. However, the efficacy of bubble suction test in abnormal tubes like hydrosalpnix has not been studied.
Read the detailed description
Nowadays, hysteroscopy is extensively used for fertility assessment. In a previous study, it is recommended to add hysteroscopy to the routine infertility work-up to achieve a better assessment of infertility cases.
In 2016, hysteroscopy as a predictor test of tubal patency and tubal peristalsis was introduced. It is concluded that hysteroscopic bubble suction test is a good initial screening test for tubal patency nearly comparable to HSG and DL. It should be attempted in every case of OH prior to referral for more invasive HSG or laparoscopic chromopertubation test.
Thereafter, some authors tried the same idea of bubble suction test and were over-enthusiastic with this test and considered it superior to hysterosalpingography (HSG) in detection of tubal patency in infertile women. They wrongly described HSG as a historic tool despite being recommended as a basic infertility test by many organizations. Some authors criticized the results of these studies and underestimated their clinical implication. One of the objections were lack of differentiation between normal tubes and damaged or narrowed but still patent tubes.
Aim of the work:
To test whether bubble suction test and osteal peristalsis are preserved or lost in cases with hydrosalpnix.
Design: A prospective double blinded randomized controlled trial.
- Conditions
- Tubal Patency
- Being tested
- Bubble suction test and tubal peristalsis
- Keywords
- laparoscopy, hysteroscopy,, tubal patency,, bubble test,, peristalsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble suction test and tubal peristalsisDiagnostic test
Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)
| Study group | Role | What they receive |
|---|---|---|
| bubble suction test and peristalsis in hydrosalpnix | . Group A: Women with unilateral or bilateral blockage of the distal end of the fallopian tubes with tubal distension. Receives: Diagnostic Test: Bubble suction test and tubal peristalsis | |
| bubble suction test and peristalsis in normal tubes | Group B: Women with normal appearance of the fallopian tubes by HSG. Receives: Diagnostic Test: Bubble suction test and tubal peristalsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of positive tests in both pathologic and healthy tubes
Bubble suction test+ tubal peristalsis
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 posted16 May 2019
- Study start10 Dec 2019
- Primary completion19 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal PatencyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953586
- Sponsor's protocol ID
- WomansHealthUHEgypt
- Status last verified
- Dec 2020
- First submitted
- 12 May 2019
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
- ClinicalTrials.gov ID
- NCT03953586
- Acronym / sponsor ID
- WomansHealthUHEgypt
- Conditions
- Tubal Patency
- Keywords
- laparoscopy, hysteroscopy,, tubal patency,, bubble test,, peristalsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 16 May 2019 (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.
Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. However, the efficacy of bubble suction test in abnormal tubes like hydrosalpnix has not been studied.
Detailed description
Nowadays, hysteroscopy is extensively used for fertility assessment. In a previous study, it is recommended to add hysteroscopy to the routine infertility work-up to achieve a better assessment of infertility cases.
In 2016, hysteroscopy as a predictor test of tubal patency and tubal peristalsis was introduced. It is concluded that hysteroscopic bubble suction test is a good initial screening test for tubal patency nearly comparable to HSG and DL. It should be attempted in every case of OH prior to referral for more invasive HSG or laparoscopic chromopertubation test.
Thereafter, some authors tried the same idea of bubble suction test and were over-enthusiastic with this test and considered it superior to hysterosalpingography (HSG) in detection of tubal patency in infertile women. They wrongly described HSG as a historic tool despite being recommended as a basic infertility test by many organizations. Some authors criticized the results of these studies and underestimated their clinical implication. One of the objections were lack of differentiation between normal tubes and damaged or narrowed but still patent tubes.
Aim of the work:
To test whether bubble suction test and osteal peristalsis are preserved or lost in cases with hydrosalpnix.
Design: A prospective double blinded randomized controlled trial.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bubble suction test and peristalsis in hydrosalpnix | – | Diagnostic Test: Bubble suction test and tubal peristalsis. Group A: Women with unilateral or bilateral blockage of the distal end of the fallopian tubes with tubal distension. |
| bubble suction test and peristalsis in normal tubes | – | Diagnostic Test: Bubble suction test and tubal peristalsisGroup B: Women with normal appearance of the fallopian tubes by HSG. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women with a history of HSG
Key inclusion criteria (1 listed)
- Infertility patients scheduled for combined laparoscopy and hysteroscopy
Key exclusion criteria (1 listed)
- No HSG
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 |
|---|---|---|
| Bubble suction test and tubal peristalsisEfficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B) | Diagnostic test | bubble suction test and peristalsis in hydrosalpnix, bubble suction test and peristalsis in normal tubes |
Primary outcome
percentage of positive tests in both pathologic and healthy tubes
Time frame: 6 months
Bubble suction test+ tubal peristalsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: Yes
Related trials for Tubal Patency
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tubal Patency, 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 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: finished, as of the sponsor's last update on 10 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of positive tests in both pathologic and healthy tubes (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 10 Dec 2020.