Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Sponsor

Ganin Fertility Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05494216

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI), magnetic activated cell sorting (MACS), and Microfluidic sperm sorting (Fertile plus) in terms of the PGT-A outcomes of each arm blastocysts

Condition or Disease	Intervention/Treatment	Phase
Sperm DNA Fragmentation Infertility	Other: PICSI Other: MACS Other: Microfluidics	N/A

Detailed Description

Advanced sperm selection methods like PICSI, MACS, and microfluidics chips 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 3 assigned sperm selection techniques.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PICSI 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 Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
Active Comparator: MACS 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 Sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Active Comparator: Microfluidics Liquified semen sample was separated using Fertile plus microfluidics chips, after separation the resulted sperm population is though to have higher progressive motility and lower Sperm DNA fragmentation that is suitable for ICSI	Other: Microfluidics Sperm selection using Fertile plus for selecting sperm with lower DNA fragmentation index Other Names: Fertile plus

Arm

Intervention/Treatment

Active Comparator: PICSI

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

Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index

Active Comparator: MACS

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

Sperm selection using MACS for selecting sperm with lower DNA fragmentation index

Active Comparator: Microfluidics

Liquified semen sample was separated using Fertile plus microfluidics chips, after separation the resulted sperm population is though to have higher progressive motility and lower Sperm DNA fragmentation that is suitable for ICSI

Other: Microfluidics

Sperm selection using Fertile plus for selecting sperm with lower DNA fragmentation index

Other Names:

Fertile plus

Outcome Measures

Primary Outcome Measures

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
High mosaic rate [15 days post ICSI]
Defined as the proportion of high mosaic blastocysts

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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