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.
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.
atef mohamed Darwish, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Women health hospital , Assuit university
Asyut, Assuit, 71515
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 .
- Conditions
- Women Health, Contraception
- 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 group | Role | What they receive |
|---|---|---|
| study group | women 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 group | women 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.
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)
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.
- First posted27 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion5 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women HealthStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Gendy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Gendy, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills) Prospective Cohort Study .
- ClinicalTrials.gov ID
- NCT05024604
- Acronym / sponsor ID
- 117101333
- Conditions
- Women Health, Contraception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Samuel GendyUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 27 Aug 2021 (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.
Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Drug: Progesterone Only Product in Oral Dose Form, Other: office hysterscopywomen receiving mini pills as a method of contraception with symptoms not diagnosed with us |
| Control group | – | Other: office hysterscopywomen attending to office hysteroscopy unit and not taking hormonal therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- maternal health and family planning
Key inclusion criteria (25 listed)
- study group:
- 2-Authorization to participate in the study .
- Control group
- 1- women attending to office hysteroscopy clinic
- study group
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Progesterone Only Product in Oral Dose Formmini pills as a contraceptive method | Drug | study group |
| office hysterscopyoffice hysteroscoy | Other | Control group, study group |
Primary outcome
primary outcome
Time frame: an average of 1 year
Hysteroscopic findings in women using POPs versus those not using hormones.( cervical mucosa , endometrium )
1 secondary outcome
subsidiary
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Women Health
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
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.
atef mohamed Darwish, MD contact
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 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.