NCT03398317|Completed
Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
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PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
Sponsor study identifier
interventional
396
1 country
1
Study Start
January 1, 2017
Actual (reported)Primary Completion
March 30, 2019
Actual (reported)Study Completion
March 30, 2019
Actual (reported)On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2017
Actual (reported)January 7, 2018
Actual (reported)January 12, 2018
Actual (reported)March 30, 2019
Actual (reported)March 30, 2019
Actual (reported)Ongoing pregnancy rate
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
20 weeks of gestation
Comparison of cleavage rate
3 days
Comparison of Blastulation rate
5-6 days
Comparison of Blastocyst quality rate
5-6 days
Comparison of Pregnancy rate
14 days following embryo transfer
Comparison of implantation rate
6- 8 weeks following embryo transfer
Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection
Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for Oocyte injection.
sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ganin Fertility Center
Cairo, Egypt
Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
Hasanen E, Elqusi K, ElTanbouly S, Hussin AE, AlKhadr H, Zaki H, Henkel R, Agarwal A. PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial. J Assist Reprod Genet. 2020 Oct;37(10):2605-2613. doi: 10.1007/s10815-020-01913-4. Epub 2020 Aug 8.
Hosam Zaki, MSc, FRCOG
Ganin Fertility Center, Cairo, Egypt
Eman Hasanen, BSc
Ganin Fertility Center, Cairo, Egypt
Khaled El Qusi, BSc
Ganin Fertility Center, Cairo, Egypt
Abd El Ghafar Hussin, BSc
Ganin Fertility Center, Cairo, Egypt
396 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2018
First Posted
January 12, 2018
Study Start
January 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
Salma El Tanbouly, BSc
Ganin Fertility Center, Cairo, Egypt
Ashok Agarwal, PhD
American Center of Reproductive Medicine, Cleveland Clinic
Ralph Henkel, PhD
University of the Western Cape
Hanaa Alkhader
Ganin Fertility Center, Cairo, Egypt
Primary Completion
March 30, 2019
Actual (reported)Study Completion
March 30, 2019
Actual (reported)Last Updated
July 21, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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