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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: ANZCTR
Last refreshed on: 26 August 2019
Main ID:  ACTRN12617000524392
Date of registration: 10/04/2017
Prospective Registration: Yes
Primary sponsor: DOAA MOHAMED SALEH
Public title: Platelet-rich plasma (PRP) local injection for female sexual dysfunction
Scientific title: Platelet- rich plasma (PRP) local injection for female sexual dysfunction
Date of first enrolment: 20/04/2017
Target sample size: 40
Recruitment status: Not yet recruiting
URL:  https://anzctr.org.au/ACTRN12617000524392.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Egypt
Contacts
Name: A/Prof nahed ezzat   
Address:  assistantprofessor OB/GYN AZHAR UNIVERSITY AL ZAHRA UNIVERISITY HOSPITAL CAIRO ,EGYPT Egypt
Telephone: +20122654789
Email: nahedallam16@gmail.com
Affiliation: 
Name: Prof taiseer marouf   
Address:  PROFESSOR OB/GYN AZHAR UNIVERSITY AL ZAHRA UNIVERISITY HOSPITAL ,CAIRO ,EGYPT Egypt
Telephone: +201223660078
Email: taiseer.maarouf@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Sexual dysfunction;
Sexual dysfunction
Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
Intervention(s)
A small sample of blood (5ml) is withdrawn from the patient, then spun in a centrifuge to separate the blood into layers.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.
Primary Outcome(s)
change in sexual function accessed by FSFIq before and after the procedure.[2 months after PRP injection]
Secondary Outcome(s)
2-change in urinary incontinence in patients complaining of incontinence.
will be assessed by ICIQ short form questionnaire.[2 months after PRP injection]
1-The incidence of vaginal infection assessed by self-report.
[2 months after PRP injection.]
Secondary ID(s)
none
Source(s) of Monetary Support
AL ZAHRAA UNIVERSITY HOSPITAL
Secondary Sponsor(s)
TAISEER MAROUF
Ethics review
Status: Not required
Approval date:
Contact:
Northern A Health and Disability Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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