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.: PACTR201601001418777 Date of Approval: 10/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Swim up method versus density gradient method in sperm preparation for ICSI in non-male factor cases.
Official scientific title Swim up method versus density gradient method in sperm preparation for ICSI in non-male factor cases .
Brief summary describing the background and objectives of the trial The present study will be conducted to determine whether there were any difference in the blastocyst formation rate in the fertilized oocytes in ICSI if the injection procedure is done with sperms prepared by swim up method versus density gradient method.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/02/2016
Actual trial start date
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 730
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used
Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Swim-up method Insemination of the oocytes with sperms prepared with swim-up method . 365
Experimental Group Desity gradient method Insemination of the oocytes with sperms prepared with density gradient method. 365
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ICSI performed for non male factor cases . - Agonist or antagonist protocol . - Baseline follicle-stimulating hormone levels <15 IU/L ICSI perfomed for male factor. Abnormal uterine factor diagnosed by Vaginal sonography, Hysteroscopy or Hysterosalpingography. Previous ICSI failures. 20 Year(s) 35 Year(s) Both
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
No 01/02/2016 Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blastocyst formation Day 5 embryo transfer
Secondary Outcome fertilization rate Day 5 embryo transfer
Secondary Outcome Cleavage Day 5 embryo transfer
Secondary Outcome Quality of embryo Day 5 embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El-Shatby University Hospital Port-said Street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Obstetrics and Gynaecology Department, Faculty of Medicine, University of Alexandria Port-said Street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obstetrics and Gynaecology Department, Faculty of Medicine, University of Alexandria Port-said Street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt
Sherif Gafaar 14 of May street, El Sayadla Builds, building number 2 #501 Smouha, Alexandria Egypt
amany mohamed ahmed Hanoo Ville Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue Janaklis
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Sherif Gafaar shgaafar301@yahoo.com 002-01224107065 14 of May street, El Sayadla Builds, building number 2 #501 Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Lecturer of Obstetrics and Gynaecology
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