Fallopian Tube Peristalsis and PatencyNCT04368104
Office Hysteroscopy in Women Using Progesterone-only Contraception (POC)
An observational study of Fallopian Tube Peristalsis and Patency and Endometrial Pattern, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fallopian Tube Peristalsis and Patency, Endometrial Pattern
- What is being tested?
- Darwish test (office hysteroscopic bubble suction and tubal peristalsis)
- How many people
- 146 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2021to 1 Jul 2023
- Phase
- Observational
- 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
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).
Who may be able to join
- women using progesterone-only contraception (POC)
- women planned for office hysteroscopy for other indication.
Who cannot join
- A suspected pregnancy.
- heavy vaginal bleeding.
- active pelvic inflammatory disease (PID).
- severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
- Other medical contraindications to pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometrial Changes and Fallopian Tubal Darwishscope Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Women Using Progesterone-only Contraception (POC) as Noticed by Office Hysteroscopy.
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.
- Being tested
- Darwish test (office hysteroscopic bubble suction and tubal peristalsis)
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, minipills, endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darwish test (office hysteroscopic bubble suction and tubal peristalsis)Diagnostic test
Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..
| Study group | Role | What they receive |
|---|---|---|
| Group A | women using any form of minipills Receives: 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. Receives: Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..
case control
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start3 Aug 2021
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube Peristalsis and PatencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368104
- Sponsor's protocol ID
- Darwish test and POC
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Changes and Fallopian Tubal Darwishscope Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Women Using Progesterone-only Contraception (POC) as Noticed by Office Hysteroscopy.
- ClinicalTrials.gov ID
- NCT04368104
- Acronym / sponsor ID
- Darwish test and POC
- Keywords
- hysteroscopy, tubal patency, bubble suction test, tubal peristalsis, minipills, endometrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)women using any form of minipills |
| Group B | – | Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)women subjected to office hysteroscopy for different indications but not using any form of hormones or systemic or local hormonal contraception. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- women using progesterone-only contraception (POC)
- women planned for office hysteroscopy for other indication.
Key exclusion criteria (5 listed)
- A suspected pregnancy.
- heavy vaginal bleeding.
- active pelvic inflammatory disease (PID).
- severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
- Other medical contraindications to pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darwish 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.. | Diagnostic test | Group A, Group B |
Primary outcome
office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones..
Time frame: 1 month
case control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Peristalsis and Patency and Endometrial Pattern, run by Woman's Health University Hospital, Egypt at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
office hysteroscopic endometrial and Fallopian tubal Darwishscope test in women using progesterone-only contraception (POC) versus non users of any hormones.. (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 27 Jul 2023.