An interventional study of PICSI and Second ejaculate in Male Infertility, sponsored by Ganin Fertility Center. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Ganin Fertility Center · Not applicable, Interventional, and Treatment
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.
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Exclusion Criteria:
Using routine semen processing method
Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
Device: PICSI
Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI
Other: Second ejaculate
Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Semen processing by density gradient centrifugation for the second ejaculate
Fertilization rate
Defined as the proportion of fertilized oocytes over the injected oocytes.
Time frame: 16-19 hours
Cleavage rate
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Time frame: 3 days
Blastulation rate
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Time frame: 5-6 days
Blastocyst quality rate
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: 5-6 days
Plan to share: Yes
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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