Infertility, Sperm DNA Fragmentation
Conditions
Keywords
Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate
Brief summary
Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts
Detailed description
Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection. PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.
Interventions
Sponsors
Ganin Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Case must have PGT-A for all of her blastocysts * Males diagnosed with abnormal sperm DNA fragmentation index (\> 20%). * Normo responder (\> 5 mature oocytes) * Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI
Exclusion criteria
* Leukocytospermia * Presence of varicocele. * Known genetic abnormality * Use of sperm or oocyte donors * Use of gestational carrier * Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection * Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High mosaic rate | 15 days post ICSI | Defined as the proportion of high mosaic blastocysts |
| Euploidy rate | 15 days post ICSI | Defined as the proportion of euploid blastocysts |
| Aneuploidy rate | 15 days post ICSI | Defined as the proportion of aneuploid blastocysts |
| Low mosaic rate | 15 days post ICSI | Defined as the proportion of low mosaic blastocysts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization rate | 1 day | Defined as the proportion of fertilizaed oocytes |
| Cleavage rate | 3 days | Defined as the proportion of cleaved embryos on day 3 |
| Blastocyst development rate | 5-6 days | Defined as the proportion of blastocysts formed on day 5 or 6 |
| Blastocyst quality rate | 5-6 days | Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor |
Countries
Egypt
Outcome results
None listed