Intrauterine PolypNCT04367415
Darwish Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Cases of Intrauterine Polyp(s)
An observational study of Intrauterine Polyp, run by Woman's Health University Hospital, Egypt at 2 sites in Egypt.
Trial summary
Anatomic Fallopian tubal patency and physiologic patency testing are feasible via hystertoscopy. This study aims to test the impact of different types of intrauterine polyp(s) on Darwish test (office hysteroscopic bubble suction test and tubal peristalsis). Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Intrauterine Polyp
- What is being tested?
- Darwish test for a free endometrial cavity and Darwish test for an endometrial cavity with endometrial polyps
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Aug 2021to 26 Dec 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 20 to 50 years
- Women only
- Adult
Study population: women with suspected intrauterine polyp(s)
Who may be able to join
- intrauterine polyp(s) as diagnosed by transvaginal ultrasonography (TVS) or saline infusion sonography (SIS).
- abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or postcoital bleeding,
- infertility.
Who cannot join
- A suspected pregnancy,
- heavy vaginal bleeding,
- active pelvic inflammatory disease (PID),
- severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Recruiting
Woman's Health University Hospital
Asyut, 71111
Atef MM Darwish, MD PhD, 0201001572723, atef_darwish@yahoo.com
- Active, not recruiting
Woman's Health University Hospital
Asyut, 71111
About this study
Anatomic Fallopian tubal patency and physiologic patency testing are feasible via hystertoscopy. This study aims to test the impact of different types of intrauterine polyp(s) on Darwish test (office hysteroscopic bubble suction test and tubal peristalsis).
Read the detailed description
It will include women with suspected intrauterine polyp(s) as diagnosed by transvaginal ultrasonography (TVS) or saline infusion sonography (SIS). They will be women complaining from abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or postcoital bleeding, or infertility. Intrauterine polyp(s) could be included based on a recent hysterosalpingography (HSG) with an intrauterine circumscribed filling defect with sharp border. Preoperative counseling of all patients followed by an informed written consent taken from those who will agree. The included patients subjected to complete history taking and meticulous physical examination. A suspected pregnancy, heavy vaginal bleeding, active pelvic inflammatory disease (PID), severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy will be exclusion criteria of this study. Selected cases will be subjected to office hysteroscopy.
Sample size calculation is based on the investigator's previous study on the prevalence of tubal patency using bubble suction test in infertility patients with normal FT. The percentage of agreement between office hysteroscopy and diagnostic laparoscopy will be 92% and 88% for the right and left tubes respectively. If it is supposed that bubble suction test would be positive in about 90% of apparently normal FT and it would be positive in about 60% of cases with intrauterine polyp(s), sample size in each group would be 51 cases needed to have a confidence level of 95% with α error of 0.05 (the real value is within ±5% of the measured/surveyed value). The vulva, vagina and the thighs will be disinfected with a 10% povidone-iodine solution. Sterile draping will be applied.
Office diagnostic hysteroscopy will be performed using a 2.6 mm 30° rigid scope with a 3.2mm outer sheath (Karl Storz, Tutlingen, Germany). At the beginning in all cases vaginoscopic approach is tried but if any difficulty will be encountered, grasping of the anterior lip of cervix with a volsellum will be done. Therafter, the uterus will be distended with normal saline at 100-150 mmHg generated from a pneumatic cuff of sphygmomanometer wrapped around the 500-cm3 infusion bottle. As attached to a 250-W Xenon light source, the scope will be introduced gently through the cervical canal and internal os. To perfectly perform hysteroscopic tubal patency testing the following tricks should be followed. Clear view of the endometrial cavity should be achieved on panoramic view by placing the hysteroscope at internal os waiting for a while to achieve homogenous distension. The uterine cavity should be systematically examined starting by its anterior and posterior walls, the fundus, and the borders. Examination will be considered complete if the both tubal ostia will be reached describing any gross pathology, e.g., septum, adhesions, polyp(s), myoma, and any growth.
If the uterine cavity is normal the patient will be allocated as group A. If there is one or more polyp(s) the patient will be allocated as group B. Localization and size estimation of the polyp(s) is mandatory.
Prerequisites for a successful access to evaluate tubal patency include utilization of a 300 telescope with gaining skill of its rotation to reach both cornea and most importantly orientation with a fundamental anatomic triad (Darwish triad) (DT). The most proximal corneal fine wide circle is the ostium (the end of the endometrial cavity) representing a base of a cone which is followed by a shallow conical groove (the first millimeters of the intramural part of FT). Finally, a distal pinhole dark spot (the narrowest part of the FT) representing the tip of the cone. Putting DT (ostium, intramural part and dark spot) in mind is the key step to evaluate tubal patency and physiology via hysteroscopy. If DT is clearly accessible, the hysteroscopist should comment on this. If there are some osteal lesions like tiny polyp(s) or fine adhesions that may hinder proper evaluation of the tubal anatomy and physiology, the hysteroscopist should notice and document. Passage of any air bubbles in the irrigating fluid towards DT is reported. If no observed air bubbles, the hysteroscopist should inject just 2 ml of air into the rubber end of the sterile infusion set. Hysteroscopic bubble suction test is considered positive if air bubbles are sucked by DT within 1 min. During this period, neither injection of air nor increased pressure will be done. If no suction of gas bubbles occurred, the examiner should wait for 1 min more to exclude tubal spasm. Again, if no suction of the bubbles by DT and their accumulation at the corneal end, the test will be considered negative. Simultaneously, careful visualization of any change in the shape of the ostium and intramural part of FT particularly during suction of the air bubbles will be recorded in all cases. Tubal peristalsis is defined as observed osteal and intramural tubal rhythmic opening and closing on maintained intrauterine pressure, i.e., periodic changes of DT in the form of widening followed by collapse on meticulous observation. If the ostium and intramural part of the tube is obviously opened followed by collapse and non-visualization of the pinhole dark spot of DT for a while, positive peristalsis will be reported. The same steps will be repeated on the contralateral side and reported.
- Conditions
- Intrauterine Polyp
- Being tested
- Darwish test for a free endometrial cavity, Darwish test for an endometrial cavity with endometrial polyps
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, infertility, Abnormal uterine bleeding
- Medical subject headings
- Infertility, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darwish test for a free endometrial cavityDiagnostic test
Darwish test (Office hysteroscopic bubble suction and tubal peristalsis). If the uterine cavity is normal the patient will be allocated as group A
Darwish test for an endometrial cavity with endometrial polypsDiagnostic test
Darwish test (Office hysteroscopic bubble suction and tubal peristalsis).If there is one or more polyp(s) the patient will be allocated as group B.
| Study group | Role | What they receive |
|---|---|---|
| Normal uterine cavity on office hysteroscopy | If the uterine cavity is normal the patient will be allocated as group A. Receives: Diagnostic Test: Darwish test for a free endometrial cavity; Diagnostic Test: Darwish test for an endometrial cavity with endometrial polyps | |
| uterine cavity shown one or more polyps on office hysteroscopy | If there is one or more polyp(s) the patient will be allocated as group B. Localization and size estimation of the polyp(s) is mandatory. Receives: Diagnostic Test: Darwish test for a free endometrial cavity; Diagnostic Test: Darwish test for an endometrial cavity with endometrial polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic and physiologic tubal patency (Office hysteroscopic bubble suction and tubal peristalsis) in cases of intrauterine polyp(s)
diagnostic test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start20 Aug 2021
- Primary completion23 Dec 2022 (estimated)
- Study completion26 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine PolypStudies 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
- 120 participants (estimated)
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
- NCT04367415
- Sponsor's protocol ID
- Darwish test and polyp(s)
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darwish Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Cases of Intrauterine Polyp(s)
- ClinicalTrials.gov ID
- NCT04367415
- Acronym / sponsor ID
- Darwish test and polyp(s)
- Conditions
- Intrauterine Polyp
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, infertility, Abnormal uterine bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 26 Dec 2022 (estimated)
- First posted
- 29 Apr 2020 (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.
Anatomic Fallopian tubal patency and physiologic patency testing are feasible via hystertoscopy. This study aims to test the impact of different types of intrauterine polyp(s) on Darwish test (office hysteroscopic bubble suction test and tubal peristalsis).
Detailed description
It will include women with suspected intrauterine polyp(s) as diagnosed by transvaginal ultrasonography (TVS) or saline infusion sonography (SIS). They will be women complaining from abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or postcoital bleeding, or infertility. Intrauterine polyp(s) could be included based on a recent hysterosalpingography (HSG) with an intrauterine circumscribed filling defect with sharp border. Preoperative counseling of all patients followed by an informed written consent taken from those who will agree. The included patients subjected to complete history taking and meticulous physical examination. A suspected pregnancy, heavy vaginal bleeding, active pelvic inflammatory disease (PID), severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy will be exclusion criteria of this study. Selected cases will be subjected to office hysteroscopy.
Sample size calculation is based on the investigator's previous study on the prevalence of tubal patency using bubble suction test in infertility patients with normal FT. The percentage of agreement between office hysteroscopy and diagnostic laparoscopy will be 92% and 88% for the right and left tubes respectively. If it is supposed that bubble suction test would be positive in about 90% of apparently normal FT and it would be positive in about 60% of cases with intrauterine polyp(s), sample size in each group would be 51 cases needed to have a confidence level of 95% with α error of 0.05 (the real value is within ±5% of the measured/surveyed value). The vulva, vagina and the thighs will be disinfected with a 10% povidone-iodine solution. Sterile draping will be applied.
Office diagnostic hysteroscopy will be performed using a 2.6 mm 30° rigid scope with a 3.2mm outer sheath (Karl Storz, Tutlingen, Germany). At the beginning in all cases vaginoscopic approach is tried but if any difficulty will be encountered, grasping of the anterior lip of cervix with a volsellum will be done. Therafter, the uterus will be distended with normal saline at 100-150 mmHg generated from a pneumatic cuff of sphygmomanometer wrapped around the 500-cm3 infusion bottle. As attached to a 250-W Xenon light source, the scope will be introduced gently through the cervical canal and internal os. To perfectly perform hysteroscopic tubal patency testing the following tricks should be followed. Clear view of the endometrial cavity should be achieved on panoramic view by placing the hysteroscope at internal os waiting for a while to achieve homogenous distension. The uterine cavity should be systematically examined starting by its anterior and posterior walls, the fundus, and the borders. Examination will be considered complete if the both tubal ostia will be reached describing any gross pathology, e.g., septum, adhesions, polyp(s), myoma, and any growth.
If the uterine cavity is normal the patient will be allocated as group A. If there is one or more polyp(s) the patient will be allocated as group B. Localization and size estimation of the polyp(s) is mandatory.
Prerequisites for a successful access to evaluate tubal patency include utilization of a 300 telescope with gaining skill of its rotation to reach both cornea and most importantly orientation with a fundamental anatomic triad (Darwish triad) (DT). The most proximal corneal fine wide circle is the ostium (the end of the endometrial cavity) representing a base of a cone which is followed by a shallow conical groove (the first millimeters of the intramural part of FT). Finally, a distal pinhole dark spot (the narrowest part of the FT) representing the tip of the cone. Putting DT (ostium, intramural part and dark spot) in mind is the key step to evaluate tubal patency and physiology via hysteroscopy. If DT is clearly accessible, the hysteroscopist should comment on this. If there are some osteal lesions like tiny polyp(s) or fine adhesions that may hinder proper evaluation of the tubal anatomy and physiology, the hysteroscopist should notice and document. Passage of any air bubbles in the irrigating fluid towards DT is reported. If no observed air bubbles, the hysteroscopist should inject just 2 ml of air into the rubber end of the sterile infusion set. Hysteroscopic bubble suction test is considered positive if air bubbles are sucked by DT within 1 min. During this period, neither injection of air nor increased pressure will be done. If no suction of gas bubbles occurred, the examiner should wait for 1 min more to exclude tubal spasm. Again, if no suction of the bubbles by DT and their accumulation at the corneal end, the test will be considered negative. Simultaneously, careful visualization of any change in the shape of the ostium and intramural part of FT particularly during suction of the air bubbles will be recorded in all cases. Tubal peristalsis is defined as observed osteal and intramural tubal rhythmic opening and closing on maintained intrauterine pressure, i.e., periodic changes of DT in the form of widening followed by collapse on meticulous observation. If the ostium and intramural part of the tube is obviously opened followed by collapse and non-visualization of the pinhole dark spot of DT for a while, positive peristalsis will be reported. The same steps will be repeated on the contralateral side and reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal uterine cavity on office hysteroscopy | – | Diagnostic Test: Darwish test for a free endometrial cavity, Diagnostic Test: Darwish test for an endometrial cavity with endometrial polypsIf the uterine cavity is normal the patient will be allocated as group A. |
| uterine cavity shown one or more polyps on office hysteroscopy | – | Diagnostic Test: Darwish test for a free endometrial cavity, Diagnostic Test: Darwish test for an endometrial cavity with endometrial polypsIf there is one or more polyp(s) the patient will be allocated as group B. Localization and size estimation of the polyp(s) is mandatory. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- women with suspected intrauterine polyp(s)
Key inclusion criteria (3 listed)
- intrauterine polyp(s) as diagnosed by transvaginal ultrasonography (TVS) or saline infusion sonography (SIS).
- abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or postcoital bleeding,
- infertility.
Key exclusion criteria (4 listed)
- A suspected pregnancy,
- heavy vaginal bleeding,
- active pelvic inflammatory disease (PID),
- severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy
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 |
|---|---|---|
| Darwish test for a free endometrial cavityDarwish test (Office hysteroscopic bubble suction and tubal peristalsis). If the uterine cavity is normal the patient will be allocated as group A | Diagnostic test | Normal uterine cavity on office hysteroscopy, uterine cavity shown one or more polyps on office hysteroscopy |
| Darwish test for an endometrial cavity with endometrial polypsDarwish test (Office hysteroscopic bubble suction and tubal peristalsis).If there is one or more polyp(s) the patient will be allocated as group B. | Diagnostic test | Normal uterine cavity on office hysteroscopy, uterine cavity shown one or more polyps on office hysteroscopy |
Primary outcome
Anatomic and physiologic tubal patency (Office hysteroscopic bubble suction and tubal peristalsis) in cases of intrauterine polyp(s)
Time frame: 1 year
diagnostic test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Polyp, run by Woman's Health University Hospital, Egypt 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 3 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atef Darwish, MD PhD (0201001572723, atef_darwish@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic and physiologic tubal patency (Office hysteroscopic bubble suction and tubal peristalsis) in cases of intrauterine polyp(s) (time frame: 1 year). 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 Aug 2021.