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.: PACTR201402000773124 Date of Approval: 18/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Blastocyst versus day 2 transfer in low responders
Official scientific title Blastocyst versus day 2 transfer in low responders women undergoing ICSI: A randmoized controlled trial
Brief summary describing the background and objectives of the trial In good responders, pregnancy rates after ICSI are improved with blastocyst transfer as cormpared to day two transfer. Since only a proportion of day two embryos attain blastocyt stage. The efficcy of blastocyst transfer in low respondes is not clear. The aim of the current prospective randomized trial is to evalute blastocyst transfer in low responders as defined by ¿Bologna consensus meeting¿
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertile females who are low responders undergoing ICSI,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 25/06/2013
Actual trial start date 25/06/2013
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date 30/06/2014
Anticipated target sample size (number of participants) 550
Actual target sample size (number of participants) 430
Recruitment status 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 Permuted block randomisation (block size =4) and the block size was not variable Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blastocyst D5 Embryo Transfer 215
Experimental Group D2 Embryo transfer D2 Embryo transfer 215
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Poor response to ovarian stimulation as defined by ESHRE consensus (the Bologna criteria) (2011) Only one immature oocyte retrieved Progesterone level at day of hCG >1.5 ng/ml Endometrial thickness <6 mm at the day of hCG 20 Year(s) 45 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 01/06/2013 Ethical Committee of Misrata National Center for infertility treatment
Ethics Committee Address
Street address City Postal code Country
LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy with cardiac pulsation Four weeks after ICSI trial
Secondary Outcome Blastocyst formation Day 5 of ICSI
Secondary Outcome Cancellation At any time during ICSI cycle
Secondary Outcome Spontaneous miscarriage Up to 20 weeks pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misrata National Center for infertility treatment LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
FUNDING SOURCES
Name of source Street address City Postal code Country
Misrata National Center for infertility treatment LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Dr Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ismail M. elfourteia LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
Abdu Alaziz Mohamed Belhaj LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
Dalal Elgizery 649 Horryia Avenue Janaklis Alexandria #402 Egypt
Rugaya Mohammad Aborawi Eldam street ¿ Yeder Misrata Libyan Arab Jamahiriya
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
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 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient information Manager
Role Name Email Phone Street address
Scientific Enquiries Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
REPORTING
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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