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.: PACTR201709002592834 Date of Approval: 07/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized controlled trial of pregnancy outcome of sequential versus day 3 and day 5 embryo transfer in cases with recurrent implantation failure
Official scientific title A randomized controlled trial of pregnancy outcome of sequential versus day 3 and day 5 embryo transfers in cases with recurrent implantation failure
Brief summary describing the background and objectives of the trial Comparing pregnancy outcome in cases of sequential ( day3+ day 5) embryo transfer versus day 3 only embryo transfer versus day 5 only embryo transfer in IVF/ICSI patients with recurrent implantation failure
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Embryo transfer, IVF/ICSI,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2015
Actual trial start date 15/04/2015
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 30/06/2017
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
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 randomization using a randomized table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomized 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 Sequential embryo transfer Day 3 + Day 5 embryo transfer 70
Experimental Group Day 3 embryo transfer Day 3 embryo transfer 70
Experimental Group Day 5 embryo transfer Day 5 embryo transfer 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 35 years or less Normal endometrial cavity on hysteroscopy Recurrent (2 or more) implantation failure Negative thrombophilia screening No hydrosalpinx No endometriosis Day 3 FSH < 10IU/L and Estradiol <80 pg/mL Antimullerian hormone 1-3 ng/mL Availability of at least 5 embryos on postfertilization check Patients not fulfilling the inclusion criteria Poor or over responders in a previous cycle or by ovarian reserve tests. 20 Year(s) 35 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 15/03/2015 Ethical committee of Airforce specialized hospital
Ethics Committee Address
Street address City Postal code Country
Elteseen (ninety street) Cairo Not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Implantation rate Pregnancy test performed 14 days after embryo transfer
Primary Outcome Clinical pregnancy rate Presence of fetal heart by ultrasound 5 weeks after embryo transfer
Secondary Outcome Miscarriage rate Ultrasound 5 weeks after embryo transfer
Secondary Outcome Multiple pregnancy rate Ultrasound 5 weeks after embryo transfer
Secondary Outcome live birth rate At the time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Air Force specialized hospital Elteseen (ninety) street Cairo Not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Airforce specialized hospital Elteseen street Cairo Not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Airforce specialized hospital Elteseen street Cairo Not available Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Haitham Torky Central axis October 6th city-Giza Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis-6th October city
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis-6 october city
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis-6th october city
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th 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