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.: PACTR201411000928146 Date of Approval: 06/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title IMSI versus ICSI in patients with severe male factor infertility and repeated ICSI failure
Official scientific title Comparative study between intracytoplasmic morphologically selected sperm injection (IMSI) versus intracytoplasmic sperm injection(ICSI) in patients with severe male factor infertility and repeated ICSI failure
Brief summary describing the background and objectives of the trial In conventional ICSI, the choice of spermatozoon is based on its motility and its normal-looking shape under 200 or 400 magnification. However, minor head malformations that can negatively affect ICSI outcome (10) are not easily detected at this degree of magnification. Therefore, new techniques such as spermatozoa preselection by hyaluronic acid binding or polarization microscopy have been developed to better select optimal spermatozoa. Recently, Bartoov et performing sperm injection after selection of motile spermatozoa at a very high magnification (6,000 to 12,000). Publications assessing the benefit of this technique (intracytoplasmic morphologically selected sperm injection [IMSI]) reported controversial results. Aim of the work To compare the results of IMSI and ICSI among infertile couples with severe male factor and repeated ICSI failure in terms of: The primary outcome measures: The number of embryos, fertilization rate, Embryo grading and implantation rate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infertility with repeated ICSI failure,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,Fertility-male
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2014
Actual trial start date 01/11/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
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 of 4 and the block size was not variable) 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 ICSI Sperm selected at x 200 magnification to be injected into mature oocyte 70
Experimental Group IMSI Sperm selected at x10,000 magnification with a Nomarski-contrast Nikson inverted microscope 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary or secondary infertility Having good ovarian reserve(AMH>1.5,AFC >5 and basal FSH< 10mIu/L ) All underwent the long luteal gonadotrophin agonist proto- Col for ovarian stimulation. All with at least one previous failed ICSI Male partner with sever oligospermia sperm conc < 5(106 Per ml) and sever teratospermia normal form <4%. Endocrine disorders Associated other medical conditions (hypertention, diabetes) Abnormal uterine factor diagnosed by vaginal sonogrphy, Hysteroscopy, Hysterosalpingography or previous uterine surgery. Stage IV endometriosis or previous ovarian surgery. Male partners with TESE (testicular epididimal sperm extraction) 18 Year(s) 37 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 01/08/2014 Ethics Committee, Faculty of Medicine, University of Alexandria
Ethics Committee Address
Street address City Postal code Country
Shtaby Aelxandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of embryos Oocytes were examined for fertilization 16-18 h after ICSI or IMSI.
Primary Outcome Fertilization rate Cleavage of the oocytes was assessed on day 2 (48 h) and day 3 (72 h) day 5 (blastocyst) before transfer into the uterus.
Primary Outcome Embryo grading. assessed on day 2 (48 h) and day 3 (72 h) day 5 (blastocyst) before transfer into the uterus.
Primary Outcome Implantation rate . Number of sacs per number of embryo transfer appear 14 days after embryo transfer by TVS
Secondary Outcome Pregnancy rate Serum B-hCG assay 14 days after embryo transfer. Clinical pregnancy will be confirmed by observing fetal cardiac pulsations 2 weeks after positive pregnancy test by trans-vaginal ultrasonography (TVS).
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
Obestetrics 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 Obestetrics and Gynaecology Department, Faculty of Medicine, University of Alexandria Port-Said Street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohmoud Morad AL Abd 29 AL Ghrfa AL Togarea Alexandria Egypt
Yasser Ibrahim Orief Sadi Gaber AL Shakh Alexandria Egypt
Tamer Hnafy Mahmoud 20 Sabongy st Saba Basha Alexandria Egypt
Nesma Ahmed Abn Gad Mohram Baa Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohmoud AL Abd Dr.mohmoudalabd@gmail.com 002-01223188208 29 AL Ghrfa AL Togarea
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obestritics and Gynaecology, Faculty of Medicine, University of Alexandria
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 Yasser orief info@yaserorief.net 00201008233121 Sadi Gaber AL Shakh
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obestritics and Gynaecology, Faculty of Medicine, University of Alexandria
REPORTING
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