Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Conditions
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Sperm DNA Fragmentation, Infertility

Intervention / Treatment
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* Other: PICSI
* Other: MACS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PICSI<br>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. Individual bound sperm selection is done followed y ICSI | Other: PICSI<br>* Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index<br>|
| Active Comparator: MACS<br>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 ICSI. | Other: MACS<br>* Sperm selection using MACS for selecting sperm with lower DNA fragmentation index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euploidy rate | Defined as the proportion of euploid blastocysts | 15 days post ICSI | 
| Aneuploidy rate | Defined as the proportion of aneuploid blastocysts | 15 days post ICSI | 
| Low mosaic rate | Defined as the proportion of low mosaic blastocysts | 15 days post ICSI | 
| High mosaic rate | Defined as the proportion of high mosaic blastocysts | 15 days post ICSI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Defined as the proportion of fertilizaed oocytes | 1 day | 
| Cleavage rate | Defined as the proportion of cleaved embryos on day 3 | 3 days | 
| Blastocyst development rate | Defined as the proportion of blastocysts formed on day 5 or 6 | 5-6 days | 
| Blastocyst quality rate | Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor | 5-6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate