Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201509001264171 Date of Registration: 12/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Unexplained infertility
Official scientific title Subendometrial vascularity and high sensitive C-reactive protein in patients with unexplained infertility undergoing endometrial scratching prior to intrauterine insemination: a randomized controlled trial
Brief summary describing the background and objectives of the trial to assess the correlation between subendometrial vascularity, high-sensitive C-reactive protein and endometrial scratching in patients with unexplained infertility undergoing intrauterine insemination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Unexplained infertility
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 20/09/2015
Actual trial start date 20/09/2015
Anticipated date of last follow up 20/04/2016
Actual Last follow-up date 12/04/2016
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endometrial scratching by Pipelle 1 minute Endometrial scratching by Pipelle for 1 minute 75
Control Group Sham technique 1 minute Pressure on the cervix by piece of gauze 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
unexplained infertility Patients with hirsutism, autoimmune disorders, endocrinopathies, endometriosis and ovarian hyperstimulation syndrome. 18 Year(s) 32 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/09/2015 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome C-reactive protein measurement 48 hours after gynecologic examination
Primary Outcome endometrial thickness on the day of hCG administration.
Primary Outcome endometrial-subendometrial vascularization on the day of hCG administration
Secondary Outcome Clinical pregnancy rate and cumulative pregnancy rate after 3 cycles of controlled ovarian stimulation and intrauterine insemination.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawahla El-Bajour +2048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com +201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Abd-Elhamid Shaheen abdelhamidshaheen@yahoo.com +201221816916 10 Quesna
City Postal code Country Position/Affiliation
Shibin Elkom +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Hytham Hamza egysmart80@gmail.com +201001359136 Berket Alsabea
City Postal code Country Position/Affiliation
Berket Alsabea +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information