Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Not Applicable

Completed

• Conditions: Sperm DNA Fragmentation; Infertility
• Interventions: Other: PICSI; Other: MACS

• Registration Number: NCT05494216
• Lead Sponsor: Ganin Fertility Center

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-06
• Study First Posted: 2022-08-09
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICSI	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
MACS	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.

Primary Outcome Measures

Name	Time	Method
Aneuploidy rate	15 days post ICSI	Defined as the proportion of aneuploid blastocysts
Euploidy rate	15 days post ICSI	Defined as the proportion of euploid 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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Maadi, Egypt