Darwish Hysteroscopic Test (Hysteroscopic Bubble Suction and Tubal Peristalsis of Darwish Triad) in Myomatous Uterus
NCT ID: NCT04357054
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2023-03-05
2023-05-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Darwish Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Cases of Intrauterine Polyp(s)
NCT04367415
Office Hysteroscopy in Women Using Progesterone-only Contraception (POC)
NCT04368104
Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
NCT02705222
Relationship Between Bladder Distention and Hysteroscopy Application
NCT01848847
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
NCT06576362
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal uterus
Darwish test
Darwish test
Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
Myomatous uterus
Darwish test
Darwish test
Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Darwish test
Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
20 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Woman's Health University Hospital, Egypt
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Atef Darwish
Professor of Obstetrics and Gynecology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Woman's Health University Hospital
Asyut, , Egypt
Woman's Health University Hospital
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Darwish test in myoma
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.