Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
NCT ID: NCT03922568
Last Updated: 2019-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
388 participants
OBSERVATIONAL
2016-08-01
2019-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Density Gradient Centrifugation (DGC)
semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume
Density Gradient Centrifugation
semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume
Physiological ICSI (PICSI)
Semen processing is done by double layer DGC 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. Hyaluronan bound sperms are selected for oocyte injection
Physiological ICSI
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. Hyaluronan bound sperms are selected for oocyte injection
Magnetic Activated Cell Sorting (MACS)
Semen processing is done by double layer DGC method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.
Magnetic Activated Cell Sorting
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 sperms suitable for oocyte injection.
Interventions
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Density Gradient Centrifugation
semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume
Physiological ICSI
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. Hyaluronan bound sperms are selected for oocyte injection
Magnetic Activated Cell Sorting
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 sperms suitable for oocyte injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ICSI cases using DGC for sperm selection
* ICSI cases using MACS for sperm selection
* ICSI cases using PICSI dishes for sperm selection
* Fresh blastocyst stage embryo transfer at
* Fresh ejaculate
Exclusion Criteria
* Frozen Embryo transfer
* Fresh cleavage stage embryo transfer
* Vanishing Twin Syndrome
* Fetal Reduction
* Preimlantation genetically screened embryo transfer
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
University of the Western Cape
OTHER
Ganin Fertility Center
OTHER
Responsible Party
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khaled Elqusi
Senior clinical embryologist
Principal Investigators
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khaled Elqusi, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center
Eman Hassanen, Bsc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center
Hanaa Alkhader, ABB( ELD)
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center
Hosam Zaki, MSc, FRCOG
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center
Ralph Henkel, PhD
Role: STUDY_DIRECTOR
University of the Western Cape
Ashok Agarwal, PhD
Role: STUDY_CHAIR
American Center of Reproductive Medicine, Cleveland Clinic
Locations
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Ganin Fertility Center
Cairo, Cairo Governorate, Egypt
Countries
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References
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Celik-Ozenci C, Jakab A, Kovacs T, Catalanotti J, Demir R, Bray-Ward P, Ward D, Huszar G. Sperm selection for ICSI: shape properties do not predict the absence or presence of numerical chromosomal aberrations. Hum Reprod. 2004 Sep;19(9):2052-9. doi: 10.1093/humrep/deh361. Epub 2004 Jun 17.
Avendano C, Franchi A, Taylor S, Morshedi M, Bocca S, Oehninger S. Fragmentation of DNA in morphologically normal human spermatozoa. Fertil Steril. 2009 Apr;91(4):1077-84. doi: 10.1016/j.fertnstert.2008.01.015. Epub 2008 Apr 28.
Said TM, Land JA. Effects of advanced selection methods on sperm quality and ART outcome: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):719-33. doi: 10.1093/humupd/dmr032. Epub 2011 Aug 25.
McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. doi: 10.1086/302351. No abstract available.
Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046. doi: 10.1097/01.ju.0000171902.28215.84. No abstract available.
Komori S, Kato H, Kobayashi S, Koyama K, Isojima S. Transmission of Y chromosomal microdeletions from father to son through intracytoplasmic sperm injection. J Hum Genet. 2002;47(9):465-8. doi: 10.1007/s100380200066.
Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.
Other Identifiers
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GFC - 003
Identifier Type: -
Identifier Source: org_study_id
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