Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04368104 |
| Other study ID # |
Darwish test and POC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Mechanisms of action of progesterone-only contraception (POC) include endometrial and
Fallopian tubal changes without any scientific documentation. We succeeded to document proper
assessment of the proximal part of the Fallopian tubes and test anatomic tubal patency as
well (Darwishscope test) via hysteroscopy. This study will test endometrial pattern and
Fallopian tubal status in women using progesterone-only contraception (POC) utilizing office
hysteroscopy.
Description:
progesterone-only contraception (POC) prevent pregnancy by thickening the mucus in the cervix
to stop sperm reaching an egg and assumed to increase Fallopian tubal motility so the
fertilized oocyte reaches the endometrial cavity too early for implantation. However, this
assumption has no scientific documentation so far. We succeeded to document visualization of
peristalsis of the proximal part of the Fallopian tubes and anatomic tubal patency as well
(Darwish test) via hysteroscopy.
Aim of study: to evaluate endometrial pattern and Darwishoscope test (office hysteroscopic
bubble suction test and proximal tubal peristalsis) in women using progesterone-only
contraception (POC).
Intervention:
It will include women using any form of minipills (Desogestrel 75 µg, or Norethisterone 350
µg), medroxy-progesterone acetate, Merina or implanon complaining from abnormal uterine
bleeding in the form of menorrhagia, metorrhagia, intermenstrual spotting or or postcoital
bleeding. Cases with suspected endometrial lesion by routine transvaginal follow-up of those
cases were also included. They will be assigned as group A. Group B will include women
subjected to office hysteroscopy for different indications but not using any form of hormones
or systemic or local hormonal contraception. 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 our previous study on the prevalence of tubal peristalsis
seen via hysteroscopy. If it is supposed that tubal peristalsis would be positive in about
40% of apparently normal FT and it would be positive in about 80% of cases taking
progesterone-only contraception (POC), sample size in each group would be 73 cases in each
group. This means 73 or more measurements/surveys are needed to have a confidence level of
90% that the real value is within ±5% of the measured/surveyed value ( 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. Thereafter, 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 Darwish test 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.
Prerequisites for a successful access to evaluate fallopian tubes via hysteroscopy 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.
