Ganin Fertility Center
Cairo, Egypt
NCT Number: NCT03398317
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.
Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.
A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.
In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Males with normalDNA fragmentation index (<19%)at the initial assessment.
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
Time frame: 20 weeks of gestation
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
Time frame: 3 days
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
Time frame: 5-6 days
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3
Time frame: 5-6 days
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts
Time frame: 14 days following embryo transfer
Defined as clinical pregnancy per transfer
Time frame: 6- 8 weeks following embryo transfer
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Ganin Fertility Center
Other
PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
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