Office Hysteroscopy in Women Using Progesterone-only Contraception (POC)
Condition: Fallopian Tube Peristalsis and Patency; Endometrial Pattern
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): Darwish test (office hysteroscopic bubble suction and tubal peristalsis)
Intervention type(s): Diagnostic Test
Intervention description(s): Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women using any form of progesterone-only contraception (POC) including minipills
        (Desogestrel 75 µg, or Norethisterone 350 µg), MPA, Merina or Implanon asigned as group A
        and women subjected to office hysteroscopy for other indications (group B).
      
Keywords: hysteroscopy; tubal patency; bubble suction test; tubal peristalsis; minipills; endometrium