Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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26 August 2019 |
Main ID: |
ACTRN12617000524392 |
Date of registration:
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10/04/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Platelet-rich plasma (PRP) local injection for female sexual dysfunction
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Scientific title:
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Platelet- rich plasma (PRP) local injection for female sexual dysfunction |
Date of first enrolment:
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20/04/2017 |
Target sample size:
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40 |
Recruitment status: |
Not yet recruiting |
URL:
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https://anzctr.org.au/ACTRN12617000524392.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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A/Prof nahed ezzat
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Address:
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assistantprofessor OB/GYN
AZHAR UNIVERSITY
AL ZAHRA UNIVERISITY HOSPITAL
CAIRO
,EGYPT
Egypt |
Telephone:
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+20122654789 |
Email:
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nahedallam16@gmail.com |
Affiliation:
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Name:
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Prof taiseer marouf
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Address:
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PROFESSOR OB/GYN
AZHAR UNIVERSITY
AL ZAHRA UNIVERISITY HOSPITAL
,CAIRO
,EGYPT
Egypt |
Telephone:
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+201223660078 |
Email:
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taiseer.maarouf@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: sexually active females 18-60 years complaining of sexual dysfunction.
Exclusion criteria: 1- psychological or mental illness.
2- male partner erectile dysfunction.
3- diabetic patients
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Sexual dysfunction; Sexual dysfunction
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Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
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Intervention(s)
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A small sample of blood (5ml) is withdrawn from the patient, then spun in a centrifuge to separate the blood into layers. The platelet-rich plasma layer is carefully extracted, then injected back into the anterior and posterior vaginal wall, G-spot and clitoris. the procedure will take about 10 minutes after local anaesthetic cream application.procedure will be done in the outpatient clinic by gynaecology specialist with minimum 3 years experience.patients will receive four times injections 2weeks a part.they will be evaluated by FSFI questionnaire after 2 months.
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Primary Outcome(s)
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change in sexual function accessed by FSFIq before and after the procedure.[2 months after PRP injection]
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Secondary Outcome(s)
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2-change in urinary incontinence in patients complaining of incontinence.
will be assessed by ICIQ short form questionnaire.[2 months after PRP injection]
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1-The incidence of vaginal infection assessed by self-report.
[2 months after PRP injection.]
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Source(s) of Monetary Support
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AL ZAHRAA UNIVERSITY HOSPITAL
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Ethics review
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Status: Not required
Approval date:
Contact:
Northern A Health and Disability Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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