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Women HealthNCT05024604

Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills)

An observational study of Women Health and Contraception, run by Samuel Gendy at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Women Health, Contraception
What is being tested?
Progesterone Only Product in Oral Dose Form and office hysterscopy
Type of treatment
Pill or oral medicine
How many people
140 participants
Where
1 siteEgypt
Study dates
1 Sep 2021to 5 Dec 2022
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: maternal health and family planning

Who may be able to join

  • study group:
  • women using POP.
  • Age: reproductive age.
  • Symptoms: abnormal uterine bleeding without an organic cause.
  • 2-Authorization to participate in the study .
  • Control group
Show all 25Show fewer
  • 1- women attending to office hysteroscopy clinic
  • Age: reproductive Age
  • Contraception use : none.
  • Hormonal use: none.
  • Symptoms: abnormal uterine bleeding without an organic cause. All women in both groups would be subjected to Trans Vaginal U.S before doing hysteroscopy .
  • Exclusion criteria:
  • study group
  • Coagulopathies
  • Any contraindications to POPs as :
  • past or current breast cancer, cirrhosis, and use of anticonvulsants
  • suspected pregnancy
  • current stroke or IHD
  • severe hypertension
  • •Any contraindications to hysteroscopy as :
  • Pelvic infection
  • Pregnancy
  • Cervical cancer
  • Heavy uterine bleeding.
  • Control group --Women using any type of hormones including COCs .

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

samuel adel gendy, master contact

+201270344523

docsamueladel1994@gmail.com

atef mohamed Darwish, MD contact

Atef_darwish@yahoo.com

Egypt1 site, 1 recruiting
  • Women health hospital , Assuit university

    Asyut, Assuit, 71515

    Recruiting

Other trials in Egypt

About this study

Official title: Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills) Prospective Cohort Study .

Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study.

Read the detailed description

Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study. versus women not using any hormonal therapy ,Office hysteroscopy would be conducted outside of the formal operating theater setting in an appropriately sized, equipped, and staffed treatment room with adjoining, private changing facilities and toilet. As the patient is aware of everything that is going on, it is advisable to organize a relaxed setting, using a protected space with a comfortable seat, Uterine distension:

When performing diagnostic hysteroscopic procedures, it is best if a non-viscous, physiologic solution is used i.e. Saline or Lactated Ringers as opposed to CO2 gas. CO2 is commonly used for diagnostic hysteroscopy but is difficult to use in the presence of blood or mucous. Adequate distention pressures (50-70 mmHG) can be achieved in the office by the use of gravity or a pressure bags. Most office based procedures are of short duration and no more than 2 liters of solution should be utilized. In this situation, it is not necessary to monitor fluid inflow, outflow and deficits in the office setting. The standard access approach to the cervix involves placing a speculum within the vagina (preferably side opening), placing single tenaculum on the anterior lip of the cervix, injecting the cervix with local anaesthesia (if necessary), and placing the rigid continuous flow hysteroscope within the cervical canal. In most patients, including nulliparous and post menopausal patients, it is not necessary to dilate the cervix prior to insertion. Once the hysteroscope is within the cervical canal, the speculum should be removed, the fluid flow is begun and the hysteroscope is advanced through the cervical canal and into the uterine cavity under direct visualization.

The endometrium will be inspected by outpatient hysteroscopy The following observations made at hysteroscopy, and reviewed in detail from the video record of the examination Glandular and stromal changes The color, thickness, texture and regularity of the endometrial stroma would be assessed during hysteroscopy Superficial vascular density Endometrial vascular density would be assessed at hysteroscopy by direct inspection of the blood vessels, and graded according to the abundance of superficial vessels observed. Superficial vascular density would be reassessed after uterine collapse and Re distention.

Vascular morphology The shape and configuration of superficial and deep endometrial vessels would be assessed at hysteroscopy. The presence of regular and irregular (neo vascular and mosaic) vascular patterns in superficial and deep vessels would be recorded and graded. The presence of petechiae and ecchymosis would be recorded.

All the above values were regraded after collapse and re distention of the uterus, provided that a clear view of the endometrium could be obtained.

Vascular distribution The distribution of superficial and deep vasculature in the endometrium would be inspected and graded as even' or 'patchy'.

Endometrial biopsies biopsies would be taken at each hysteroscopy. A small amount of endometrial tissue was obtained under direct vision using the biopsy curette (novak curette). also a detailed comment by the examiner would be given regarding the uterine ostium of the fallopian tube \& any changes in the cervical canal and the cervical secretions any abnormal findings or pathology would be mentioned also .

Being tested
Progesterone Only Product in Oral Dose Form, office hysterscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progesterone Only Product in Oral Dose FormDrug

    mini pills as a contraceptive method

  • office hysterscopyOther

    office hysteroscoy

Study groups in NCT05024604
Study groupRoleWhat they receive
study groupwomen receiving mini pills as a method of contraception with symptoms not diagnosed with us
Receives: Drug: Progesterone Only Product in Oral Dose Form; Other: office hysterscopy
Control groupwomen attending to office hysteroscopy unit and not taking hormonal therapy
Receives: Other: office hysterscopy

What is being measured

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

  1. primary outcome

    Hysteroscopic findings in women using POPs versus those not using hormones.( cervical mucosa , endometrium )

    Measured: an average of 1 year

Secondary outcomes (1)
  1. subsidiary

    documentation of the local effects of POPs as a method of contraception

    Measured: an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion5 Dec 2022 (estimated)

Resources

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
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024604
Sponsor's protocol ID
117101333
Status last verified
Aug 2021
First submitted
4 Aug 2021
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Women Health and Contraception, run by Samuel Gendy 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 25 inclusion and 0 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 27 Aug 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact samuel adel gendy, master (+201270344523, docsamueladel1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary outcome (time frame: an average of 1 year). 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 Aug 2021.

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