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.: PACTR201512001356181 Date of Approval: 21/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Frozen blastocyst versus frozen 2 pronuclear embryos (2PN)
Official scientific title Comparison between frozen blastocyst ET and frozen 2PN embryo transfer
Brief summary describing the background and objectives of the trial we do icsi for all our patieints if we have enough mature oocytes we will transfer fresh 2 embryos and freeze remaining we will freeze either 2PN stage or blastocyst will freeze blastocyst in one group , freeze 2PN in other group then after thawing culture 2PN till blastocyst in case of @pn freezing we will thaw all 2PN and culture them to blastocyst stage the transfer maximum 2 balstocyst
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Artificial Reproductive Technology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2015
Actual trial start date 01/12/2016
Anticipated date of last follow up 01/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 230
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
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Embryo transfer of 2 frozen blastocyst after thawing 2 thawed blastocyst 15 minutes n/a 115 Active-Treatment of Control Group
Experimental Group Frozen 2PN 2 cultured blastocyst 15 min n/a 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
20-39 years old oocytic count >7 enough numbers of G1 embryos to freeze >39years <20 years low number of oocyte <7 low quality of embryos 20 Year(s) 39 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
No 25/11/2015 CUH ethical comittee
Ethics Committee Address
Street address City Postal code Country
Kasr alaini Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome clinical pregnancy rate 6 weeks gestation
Secondary Outcome implantation rate 6weeks gestations
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University ART kasr alainy Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University kasr alainy cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University kasr alainy cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed H Awad zulfakar st cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 00201111765934 24 abdelrahman elbarkoky almanyal
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Cairo university
Role Name Email Phone Street address
Public Enquiries Yosra Hassan yosran3@gmail.com 000201111766018 manyal st
City Postal code Country Position/Affiliation
cairo 11553 Egypt Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 zulfakar st
City Postal code Country Position/Affiliation
cairo 11553 Egypt cairo 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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information