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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Atef MM Darwish, Prof contact

0201001572723

atef_darwish@yahoo.com

Egypt2 sites, 2 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

    Recruiting

Other trials in Egypt

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 groups in NCT04357054
Study groupRoleWhat they receive
Normal uterusActive comparatorDarwish test
Receives: Diagnostic Test: Darwish test
Myomatous uterusActive comparatorDarwish test
Receives: Diagnostic Test: Darwish test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted22 Apr 2020
  2. Study start5 Mar 2023 (estimated)
  3. Primary completion23 May 2023 (estimated)
  4. Study completion25 May 2023 (estimated)

Resources

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)
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

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.

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