Ultrasound and Psychobiological Correlates of Female Sexual Function

Study Overview
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Brief Summary
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Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler ultrasonographic parameters in a population of sexually healthy volunteer women in order to obtain reference values. Psychobiological correlates of female sexual function will also be studied through hormonal testing and psychological evaluation.

Official Title
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Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function

Conditions
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Healthy

Intervention / Treatment
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* Other: clitoral, transvaginal and transrectal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sexually healthy evidence of a personally signed and dated informed consent. Exclusion Criteria: any uncontrolled or unstable, acute or chronic disease alcohol or drugs abuse sexual dysfunction any overt psychiatric or psychological condition assessed through psychological evaluation and/or self-administered validated questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sexually healthy women<br>20 sexually healthy volunteer women will be enrolled from subjects consulting our outpatient clinic (subjects free from sexual dysfunction). Hormonal and ultrasound parameters and self-administered questionnaires will be evaluated. | Other: clitoral, transvaginal and transrectal ultrasound<br>* Doppler Ultrasound assessment of clitoral hemodynamics will be performed in all subjects. Transvaginal and transrectal ultrasound will be performed in subjects giving their consent to these procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clitoral artery peak systolic velocity and acceleration | This will not be evaluated in different time frames but evaluated in order to assess reference values in sexually healthy women and compared with subjects with sexual dysfunction. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female sexual function assessed through the Female Sexual Function Index (FSFI) |  | baseline | 
| General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ) | See above | baseline | 
| Body image is investigated through the Body Uneasiness Test (BUT) |  | baseline | 
| Measurement of the thickness of the urethrovaginal space |  | baseline | 
| Measurement of the thickness of the endometrial lining |  | baseline | 
| Hormonal parameters (17β-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG) |  | baseline | 
| Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin) |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, Vagina/ultrasonography, clitoris, sexuality, vascularization, doppler, ultrasound, reference, Pilot Projects, Urethra/ultrasonography, Regional Blood Flow/physiology, Arteries/ultrasonography, Clitoris/ultrasonography, Reference values, Clitoris/blood supply