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.: PACTR201308000581376 Date of Approval: 04/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Blastocyst transfer in ICSI cycles for male factor infertility.
Official scientific title Blastocyst versus day 2 transfer in ICSI cycles for male factor infertility: A multicenter Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Pregnancy rates after ICSI are better with blastocyst transfer than day 2 transfer. The eficacy of blastocyst transfer in male factor infertility is not clear. The aim of the current prospective randomized trial is to evaluate blastocyst transfer in male factor infertility as defined by WHO criteria (2010) as compared to day 2 transfer.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertile couples with male factor infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,Fertility-male
Purpose of the trial blastocyst transfer
Anticipated trial start date 25/06/2013
Actual trial start date 25/06/2013
Anticipated date of last follow up 24/03/2014
Actual Last follow-up date 24/03/2014
Anticipated target sample size (number of participants) 326
Actual target sample size (number of participants) 326
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, block size not variable) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blastocyst group D5 Embryo Transfer 163
Control Group D2 D2 Embryo transfer 163 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male factor according to WHO (2010) Count <15 millions Total motility <40% Poor response to ovarian stimulation as defined by ESHRE consensus (the Bologna criteria) (2011) At least two of the following three features must be present: Advanced maternal age (¿40 years) or any other risk factor for POR; A previous POR (¿3 oocytes with a conventional stimulation protocol); An abnormal ovarian reserve test (i.e. AFC ,5¿7 follicles or AMH ,0.5¿1.1 ng/ml). 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 01/08/2013 Medical Ethical Committe of Misrata National Center for infertility Management
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 ET
Secondary Outcome Multiple pregnancy Five weeks after ET
Secondary Outcome Spontaneous miscarriage Up to 20 weeks pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria ICSI/IVF Center 4 Mogahedin street el Hedaya Alexandria Egypt
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 Management LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ghalia Milad Ben Sharea LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
Abdu Alaziz Mohamed Belhaj Nade Alshomoa Algeran Alexandria Libyan Arab Jamahiriya
Mai Hassan Aly Hassan 649 Horria Avenus, Janaklis Alexandria 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 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 Egypt
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 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