Tubal PatencyNCT04825041
Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test.
An observational study of Tubal Patency, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Tubal Patency
- What is being tested?
- Patency test
- How many people
- 155 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 27 Sep 2022
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertility women
Who may be able to join
- infertile women
- Probably patent FT as proved by a previous hysterosalpingography or laparoscopy.
- Office setting.
- Postmenstrual
- Non use of hormones or hormonal contraceptives.
Who cannot join
- Premenstrual period. Pathologic FT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hysteroscopic Bubble Test, Flow Test, and Peristalsis Test.
Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.
Read the detailed description
This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.
- Conditions
- Tubal Patency
- Being tested
- Patency test
- Keywords
- hysteroscopy, bubble flow test, Flow test, Peristalsis, Darwishscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patency testDiagnostic test
Successive flow test, bubble flow test and peristalsis test
| Study group | Role | What they receive |
|---|---|---|
| Infertilite women | Subjected to three successive hysteroscopic tests Receives: Diagnostic Test: Patency test |
What is being measured
The primary outcome is the main question the study is designed to answer.
FT patency
Success of each diagnostic test to assess FT patency.
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 Apr 2021
- Study start1 Sep 2021
- Primary completion22 Sep 2022
- Study completion27 Sep 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 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
- NCT04825041
- Sponsor's protocol ID
- 2021
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2021
- Last updated
- 23 Jan 2024
- 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 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hysteroscopic Bubble Test, Flow Test, and Peristalsis Test.
- ClinicalTrials.gov ID
- NCT04825041
- Acronym / sponsor ID
- 2021
- Conditions
- Tubal Patency
- Keywords
- hysteroscopy, bubble flow test, Flow test, Peristalsis, Darwishscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 1 Apr 2021 (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.
Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.
Detailed description
This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertilite women | – | Diagnostic Test: Patency testSubjected to three successive hysteroscopic tests |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertility women
Key inclusion criteria (5 listed)
- infertile women
- Probably patent FT as proved by a previous hysterosalpingography or laparoscopy.
- Office setting.
- Postmenstrual
- Non use of hormones or hormonal contraceptives.
Key exclusion criteria (1 listed)
- Premenstrual period. Pathologic FT.
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 |
|---|---|---|
| Patency testSuccessive flow test, bubble flow test and peristalsis test | Diagnostic test | Infertilite women |
Primary outcome
FT patency
Time frame: 6 months
Success of each diagnostic test to assess FT patency.
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 23 Jan 2024.
- Individual participant dataSharing planned: No
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 5 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 23 Jan 2024. 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?
FT patency (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 Jan 2024.