NCT05833685

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

April 16, 2023

Last Update Submit

September 24, 2023

Conditions

Keywords

Core Muscles, machine learning,female sexual dysfunction, KNN

Outcome Measures

Primary Outcomes (1)

  • Diaphragm excursion

    Ultrasound imaging curvilinear transducer

    2 months

Secondary Outcomes (1)

  • Force of contraction of pelvic floor muscles

    2 months

Study Arms (2)

Female sexual dysfunction group

Other: no intervention

Normal females

Other: no intervention

Interventions

no intervention

Female sexual dysfunction groupNormal females

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • a number of parities ≤ three
  • normal vaginal deliveries

You may not qualify if:

  • History of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection,
  • diabetes,
  • intrauterine device
  • sexual disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university

Minya, Minya Governorate, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

February 1, 2023

Primary Completion

April 10, 2023

Study Completion

April 15, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations