ClinicalTrials.gg
CompletedNCT04368104Updated Jul 27, 2023

Office Hysteroscopy in Women Using Progesterone-only Contraception (POC)

An observational study in Fallopian Tube Peristalsis and Patency and Endometrial Pattern, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Woman's Health University Hospital, Egypt · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
146
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fallopian Tube Peristalsis and Patency
  • Endometrial Pattern

Keywords

  • hysteroscopy
  • tubal patency
  • bubble suction test
  • tubal peristalsis
  • minipills
  • endometrium
03

In context

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women using progesterone-only (POC)
  • women planned for office hysteroscopy for other indication.

Exclusion criteria

Exclusion Criteria:

  • A suspected pregnancy.
  • heavy vaginal bleeding.
  • active pelvic inflammatory disease (PID).
  • severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
  • Other medical to pregnancy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

    women using any form of minipills

    Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)

  • Group B

    women subjected to office hysteroscopy for different indications but not using any form of hormones or systemic or local hormonal contraception.

    Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)

Interventions

  • Diagnostic testDarwish test (office hysteroscopic bubble suction and tubal peristalsis)

    Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..

06

What researchers measure

Primary outcomes

  1. office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..

    case control

    Time frame: 1 month

07

Study locations

1 site
  • Woman's Health University Hospital
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2021 to primary completion in Jun 2023, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2020
First posted
Apr 29, 2020
StartActual
Aug 3, 2021
Primary completionActual
Jun 1, 2023
CompletionActual
Jul 1, 2023
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04368104
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
Professor Atef Darwish (Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Apr 29, 2020
Start date
Aug 3, 2021
Primary completion
Jun 1, 2023
Completion
Jul 1, 2023
Last update
Jul 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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