Female Sexual DysfunctionNCT05833685
Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning
An observational study of Female Sexual Dysfunction, run by Deraya University at 1 site in Egypt.
Trial summary
The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Apr 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 30 to 40 years
- Women only
- Adult
Study population: 100 patients were distributed randomly into two groups. Female sexual dysfunction group and another group is normal females. Two group will be measure Transverses muscle ratio, Multifidus muscle ratio ,diaphragm excursion and force of contraction of pelvic floor muscles by ultrasound imaging, VLQ and FSFI questionnaires for female sexual function VLQ and FSFI questionnaires for female sexual dysfunction and normal females. Patients will be examined by radiologist with medical ultrasound imaging
Who may be able to join
- a number of parities ≤ three
- normal vaginal deliveries
Who cannot join
- History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
- diabetes,
- intrauterine device
- sexual disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse. One potential cause of FSD is muscular weakness or changes in the core muscles. These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD. Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.
- Conditions
- Female Sexual Dysfunction
- Being tested
- no intervention
- Keywords
- Core Muscles, machine learning,female sexual dysfunction, KNN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Female sexual dysfunction group | Not described Receives: Other: no intervention | |
| Normal females | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm excursion
Ultrasound imaging curvilinear transducer
Measured: 2 months
Secondary outcomes (1)
Force of contraction of pelvic floor muscles
ultrasound imaging, convex transducer was used at a frequency of 5 MHz for evaluating. Voluntary PFM contractions' force (strength) of all patients. It has a good inter-rater reliability for measuring PFM force (ICC, 0.81, 0.7123) respectively, as well as a good intra-rater reliability (ICC,0.98, 0.9841) respectively
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Feb 2023
- Primary completion10 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833685
- Sponsor's protocol ID
- P.REC/ 6/2023
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2023
- Last updated
- 26 Sep 2023
- Results posted
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Changes in Core Muscles During Female Sexual Dysfunction: A Comprehensive Analysis Using Machine and Deep Learning
- ClinicalTrials.gov ID
- NCT05833685
- Acronym / sponsor ID
- P.REC/ 6/2023
- Conditions
- Female Sexual Dysfunction
- Keywords
- Core Muscles, machine learning,female sexual dysfunction, KNN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 27 Apr 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.
The purpose of this study is to Predicting changes in core muscles during female sexual dysfunction by A Comprehensive Analysis Using Machine and Deep Learning Female sexual dysfunction (FSD) is a common condition that affects womenof all ages. It is characterized by a range of symptoms, including decreased libido, difficulty achieving orgasm, and pain during intercourse. One potential cause of FSD is muscular weakness or changes in the core muscles. These muscles play an important role in sexual function, and changes in their strength or activation patterns can lead to FSD. Additionally, the development of a machine learning model for this purpose could pave the way for future studies exploring the use of artificial intelligence in the diagnosis and treatment of other musculoskeletal disorder and female health issues.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female sexual dysfunction group | – | Other: no intervention |
| Normal females | – | Other: no intervention |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 100 patients were distributed randomly into two groups. Female sexual dysfunction group and another group is normal females. Two group will be measure Transverses muscle ratio, Multifidus muscle ratio ,diaphragm excursion and force of contraction of pelvic floor muscles by ultrasound imaging, VLQ and FSFI questionnaires for female sexual function VLQ and FSFI questionnaires for female sexual dysfunction and normal females. Patients will be examined by radiologist with medical ultrasound imaging
Key inclusion criteria (2 listed)
- a number of parities ≤ three
- normal vaginal deliveries
Key exclusion criteria (4 listed)
- History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
- diabetes,
- intrauterine device
- sexual disorder
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 |
|---|---|---|
| no interventionno intervention | Other | Female sexual dysfunction group, Normal females |
Primary outcome
Diaphragm excursion
Time frame: 2 months
Ultrasound imaging curvilinear transducer
1 secondary outcome
Force of contraction of pelvic floor muscles
Time frame: 2 months
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 26 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Female Sexual Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Active, not recruiting
Systematic Intervention to Improve Sexual Dysfunction
Breast Cancer Female, Localized Cancer
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
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 Female Sexual Dysfunction, run by Deraya 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 2 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: finished, as of the sponsor's last update on 26 Sep 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?
Diaphragm excursion (time frame: 2 months). 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 26 Sep 2023.