Clitoris VascularityNCT06084728
3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women
An observational study of Clitoris Vascularity, run by Cairo University at 1 site in Egypt.
Trial summary
Patients will be divided into two groups: Group A: 30 pregnant women Group B: 30 non pregnant women as control group. All patients will be subjected to the following: 1. Interview with women for detailed history taking and explaining the research. 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
- Clitoris Vascularity
- What is being tested?
- Color Doppler ultrasonography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Aug 2025
- 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: Both pregnant and non pregnant women between 18 and 45 years old
Who may be able to join
- Both pregnant and non pregnant women between 18 and 45 years old
Who cannot join
- Women with genital anomalies
- Virgins
- Women with gynecological disorders as endometriosis or pelvic pathology causing pelvic congestion
- Genital inflammations or mases Neurological or vascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Patients will be divided into two groups:
Group A: 30 pregnant women Group B: 30 non pregnant women as control group.
Read more
All patients will be subjected to the following:
- Interview with women for detailed history taking and explaining the research. A written Consent will be obtained from them before their enrollment into the study.
- To ensure standard conditions, the subjects will lie in a recumbent position and were evaluated between 08.00 and 11.00 a.m. To avoid anyexternal genital stimulation, subjects will be asked not to wear trousers or cross their legs on the morning of the ultrasound examination.
- Furthermore, in order to minimize external effects on blood flow, all women will be scanned in a noiseless room with constant heat and light
Read the detailed description
Patients will be divided into two groups:
Group A: 30 pregnant women Group B: 30 non pregnant women as control group. Translabial ultrasound scanning will be performed for each woman with Sonographic measurements of the clitoral volume and labia minora thickness performed by using a RSP-16 multi frequency transducer. The transducer will be placed on the upper part of the vulva to assess the clitoris in a transverse section and on the labia majora for the sagittal view. To prevent artifacts, care will be taken to avoid excessive pressure on the clitoris. The clitoris was studied where the paired corpora join in a single body that projects into the glans. Volumes were measured by reporting length, width, and depth assuming the form to be an ellipsoid: V = π/6 × D1 × D2 × D3, where D1, D2, and D3 are the maximal longitudinal, anteroposterior, and transverse diameter, respectively. The same transducer will be sagittally placed on each labium major to measure labia minora thickness, ensuring that the minimum possible pressure is applied with the ultrasound probe on the skin.
Color Doppler ultrasonography will be used to identify, in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) will be visualized posterolaterally to the labia majora (at about 2 cm from the clitoral hood).
- Conditions
- Clitoris Vascularity
- Being tested
- Color Doppler ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Doppler ultrasonographyDiagnostic test
Also called Doppler
in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) was visualized posterolaterally to the labia majora
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | 30 pregnant women. Receives: Diagnostic Test: Color Doppler ultrasonography | |
| Non-pregnant women | 30 non pregnant women as control group Receives: Diagnostic Test: Color Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak systolic velocity of the clitoreal artery
The peak systolic velocity of the clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second
Measured: At time of Doppler assessment
The pulsatility index of clitoreal artery
The pulsatility index of clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second
Measured: At time of Doppler assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startAug 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clitoris VascularityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Mostafa Seleem, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084728
- Sponsor's protocol ID
- 72
- Status last verified
- Jun 2024
- First submitted
- 1 Oct 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ultrasound and Color Doppler Studies of the Clitoris in Pregnant Women
- ClinicalTrials.gov ID
- NCT06084728
- Acronym / sponsor ID
- 72
- Conditions
- Clitoris Vascularity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Oct 2023 (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.
Patients will be divided into two groups:
Group A: 30 pregnant women Group B: 30 non pregnant women as control group.
All patients will be subjected to the following:
- Interview with women for detailed history taking and explaining the research. A written Consent will be obtained from them before their enrollment into the study.
- To ensure standard conditions, the subjects will lie in a recumbent position and were evaluated between 08.00 and 11.00 a.m. To avoid anyexternal genital stimulation, subjects will be asked not to wear trousers or cross their legs on the morning of the ultrasound examination.
- Furthermore, in order to minimize external effects on blood flow, all women will be scanned in a noiseless room with constant heat and light
Detailed description
Patients will be divided into two groups:
Group A: 30 pregnant women Group B: 30 non pregnant women as control group. Translabial ultrasound scanning will be performed for each woman with Sonographic measurements of the clitoral volume and labia minora thickness performed by using a RSP-16 multi frequency transducer. The transducer will be placed on the upper part of the vulva to assess the clitoris in a transverse section and on the labia majora for the sagittal view. To prevent artifacts, care will be taken to avoid excessive pressure on the clitoris. The clitoris was studied where the paired corpora join in a single body that projects into the glans. Volumes were measured by reporting length, width, and depth assuming the form to be an ellipsoid: V = π/6 × D1 × D2 × D3, where D1, D2, and D3 are the maximal longitudinal, anteroposterior, and transverse diameter, respectively. The same transducer will be sagittally placed on each labium major to measure labia minora thickness, ensuring that the minimum possible pressure is applied with the ultrasound probe on the skin.
Color Doppler ultrasonography will be used to identify, in a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) will be visualized posterolaterally to the labia majora (at about 2 cm from the clitoral hood).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Color Doppler ultrasonography30 pregnant women. |
| Non-pregnant women | – | Diagnostic Test: Color Doppler ultrasonography30 non pregnant women as control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both pregnant and non pregnant women between 18 and 45 years old
Key inclusion criteria (1 listed)
- Both pregnant and non pregnant women between 18 and 45 years old
Key exclusion criteria (4 listed)
- Women with genital anomalies
- Virgins
- Women with gynecological disorders as endometriosis or pelvic pathology causing pelvic congestion
- Genital inflammations or mases Neurological or vascular disorders
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 |
|---|---|---|
| Color Doppler ultrasonographyAlso: Dopplerin a longitudinal plane, the dorsal clitoral artery, which is sampled on the outer surface of the clitoral body as previously described. With the same longitudinal approach, the terminal branch of the posterior labial artery (a branch of the internal pudendal artery) was visualized posterolaterally to the labia majora | Diagnostic test | Non-pregnant women, Pregnant women |
Primary outcome
The peak systolic velocity of the clitoreal artery
Time frame: At time of Doppler assessment
The peak systolic velocity of the clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second
The pulsatility index of clitoreal artery
Time frame: At time of Doppler assessment
The pulsatility index of clitoreal artery using Doppler machine to measure Blood supply to the body of clitoris in cm/second
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
Mostafa Seleem principal investigator
Cairo University
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 Clitoris Vascularity, run by Cairo University 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 1 inclusion and 4 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 20 Jun 2024. 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 Mostafa Seleem, MD (+201001413128, mostafasaleem@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak systolic velocity of the clitoreal artery (time frame: At time of Doppler assessment). The study lists 2 primary outcomes in all. 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 20 Jun 2024.