Tubal Patency and Peristalsis During HysteroscopyNCT04357054
Darwish Hysteroscopic Test (Hysteroscopic Bubble Suction and Tubal Peristalsis of Darwish Triad) in Myomatous Uterus
A study testing Darwish test in people with Tubal Patency and Peristalsis During Hysteroscopy, run by Woman's Health University Hospital, Egypt at 2 sites in Egypt.
Trial summary
This study aims to test the impact of different types of liomyoma on Darwish test (hysteroscopic bubble suction test and tubal peristalsis of Darwish triad ) in women subjected to postmenstrual combined laparoscopy and hysteroscopy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Tubal Patency and Peristalsis During Hysteroscopy
- What is being tested?
- Darwish test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Mar 2023to 25 May 2023
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
Who cannot join
- A suspected pregnancy, 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Woman's Health University Hospital
Asyut, 71111
Atef MM Darwish, MD PhD, 0201001572723, atef_darwish@yahoo.com
- Recruiting
Woman's Health University Hospital
Asyut, 71111
Atef MM Darwisjh, MD PhD, 0201001572723, atef_darwish@yahoo.com
About this study
This study aims to test the impact of different types of liomyoma on Darwish test (hysteroscopic bubble suction test and tubal peristalsis of Darwish triad ) in women subjected to postmenstrual combined laparoscopy and hysteroscopy.
Read the detailed description
It will include infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up. 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, 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. All cases should have basic TVS examination, normal husband's semen analysis, and a recent HSG. Basic TVs should comment on any uterine pathology . If a uterine myoma is seen with its characteristic hypoechoic, but can be isoechoic, or even hyperechoic shadow compared to normal myometrium. Calcification is seen as echogenic foci with posterior shadowing. Cystic areas of necrosis or degeneration may be seen. Definition of the number, site and proximity to corneal ends of the uterus should be addressed.
Sample size calculation based on our previous study on the prevalence of tubal patency using bubble suction test in infertility patients with normal FT (5). 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 liomyomata, 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). Eligible women will subjected to combined laparoscopy and hysteroscopy essentially postmenstrual. Since this study will include infertility patients consenting for all options of endoscopic management of any infertility problem, a decision of general anesthesia will be made in all cases. The abdomen, vulva, vagina and the thighs will be disinfected with a 10% povidone-iodine solution. Sterile draping will be applied. The procedure started by a standard double puncture laparoscopy to search for any possible cause of infertility. An additional auxiliary portal will be made whenever a therapeutic procedure is needed. After completion of laparoscopic procedures to enhance fertility like myomectomy, adhesiolysis or management of endometriosis, tubal perchromation test using methylene blue dye will be done with comment on tubal patency in both sides. FT length, integrity, size, external surface and fimbriae will be reported bilaterally.
Thereafter, conventional diagnostic hysteroscopy will be performed using a 4mm 30° rigid scope with a 5mm outer sheath (Karl Storz, Tutlingen, Germany), and 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 as previously described (5). 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, myoma, and growth.
If the uterus appears externally and internally normal , the patient allocated as group A. If there is one or more liomyomata the patient allocated as group B.
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 polypi or fine adhesions (figure 3, video 2) 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 (figure 4). 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 repeated on the contralateral side and reported.
- Being tested
- Darwish test
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, liomyoma, Darwish test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darwish testDiagnostic test
Also called hysteroscopic bubble suction and tubal peristalsis of Darwish triad
Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
| Study group | Role | What they receive |
|---|---|---|
| Normal uterus | Active comparator | Darwish test Receives: Diagnostic Test: Darwish test |
| Myomatous uterus | Active comparator | Darwish test Receives: Diagnostic Test: Darwish test |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive bubble suction and tubal peristalsis (Darwish test) in women with myomata and those without.
Diagnostic tubal patency test via hysteroscopy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start5 Mar 2023 (estimated)
- Primary completion23 May 2023 (estimated)
- Study completion25 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal Patency and Peristalsis During HysteroscopyStudies 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
- Parallel groups
- Model description
- hysteroscopic bubble suction and tubal peristalsis
- Masking
- None (open label)
- 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
- NCT04357054
- Sponsor's protocol ID
- Darwish test in myoma
- Status last verified
- Feb 2023
- First submitted
- 19 Apr 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darwish Hysteroscopic Test (Hysteroscopic Bubble Suction and Tubal Peristalsis of Darwish Triad) in Myomatous Uterus
- ClinicalTrials.gov ID
- NCT04357054
- Acronym / sponsor ID
- Darwish test in myoma
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, liomyoma, Darwish test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 5 Mar 2023 (estimated)
- Primary completion
- 23 May 2023 (estimated)
- Study completion
- 25 May 2023 (estimated)
- First posted
- 22 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.
This study aims to test the impact of different types of liomyoma on Darwish test (hysteroscopic bubble suction test and tubal peristalsis of Darwish triad ) in women subjected to postmenstrual combined laparoscopy and hysteroscopy.
Detailed description
It will include infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up. 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, 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. All cases should have basic TVS examination, normal husband's semen analysis, and a recent HSG. Basic TVs should comment on any uterine pathology . If a uterine myoma is seen with its characteristic hypoechoic, but can be isoechoic, or even hyperechoic shadow compared to normal myometrium. Calcification is seen as echogenic foci with posterior shadowing. Cystic areas of necrosis or degeneration may be seen. Definition of the number, site and proximity to corneal ends of the uterus should be addressed.
Sample size calculation based on our previous study on the prevalence of tubal patency using bubble suction test in infertility patients with normal FT (5). 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 liomyomata, 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). Eligible women will subjected to combined laparoscopy and hysteroscopy essentially postmenstrual. Since this study will include infertility patients consenting for all options of endoscopic management of any infertility problem, a decision of general anesthesia will be made in all cases. The abdomen, vulva, vagina and the thighs will be disinfected with a 10% povidone-iodine solution. Sterile draping will be applied. The procedure started by a standard double puncture laparoscopy to search for any possible cause of infertility. An additional auxiliary portal will be made whenever a therapeutic procedure is needed. After completion of laparoscopic procedures to enhance fertility like myomectomy, adhesiolysis or management of endometriosis, tubal perchromation test using methylene blue dye will be done with comment on tubal patency in both sides. FT length, integrity, size, external surface and fimbriae will be reported bilaterally.
Thereafter, conventional diagnostic hysteroscopy will be performed using a 4mm 30° rigid scope with a 5mm outer sheath (Karl Storz, Tutlingen, Germany), and 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 as previously described (5). 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, myoma, and growth.
If the uterus appears externally and internally normal , the patient allocated as group A. If there is one or more liomyomata the patient allocated as group B.
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 polypi or fine adhesions (figure 3, video 2) 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 (figure 4). 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 repeated on the contralateral side and reported.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- hysteroscopic bubble suction and tubal peristalsis
| Arm | Type | Receives |
|---|---|---|
| Normal uterus | Active comparator | Diagnostic Test: Darwish testDarwish test |
| Myomatous uterus | Active comparator | Diagnostic Test: Darwish testDarwish test |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
Key exclusion criteria (1 listed)
- A suspected pregnancy, 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.
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 testAlso: hysteroscopic bubble suction and tubal peristalsis of Darwish triadInfertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up. | Diagnostic test | Myomatous uterus, Normal uterus |
Primary outcome
positive bubble suction and tubal peristalsis (Darwish test) in women with myomata and those without.
Time frame: 1 month
Diagnostic tubal patency test via hysteroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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?
A study testing Darwish test in people with Tubal Patency and Peristalsis During Hysteroscopy, 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 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 (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?
positive bubble suction and tubal peristalsis (Darwish test) in women with myomata and those without. (time frame: 1 month). 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 8 Feb 2023.