Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Infertility Clinical Trial

Official title:

Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494216
• Other study ID #: GFC-005
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2024
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Sperm DNA Fragmentation

Intervention

Other:
• PICSI
Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
• MACS
Sperm selection using MACS for selecting sperm with lower DNA fragmentation index

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Euploidy rate	Defined as the proportion of euploid blastocysts	15 days post ICSI
Primary	Aneuploidy rate	Defined as the proportion of aneuploid blastocysts	15 days post ICSI
Primary	Low mosaic rate	Defined as the proportion of low mosaic blastocysts	15 days post ICSI
Primary	High mosaic rate	Defined as the proportion of high mosaic blastocysts	15 days post ICSI
Secondary	Fertilization rate	Defined as the proportion of fertilizaed oocytes	1 day
Secondary	Cleavage rate	Defined as the proportion of cleaved embryos on day 3	3 days
Secondary	Blastocyst development rate	Defined as the proportion of blastocysts formed on day 5 or 6	5-6 days
Secondary	Blastocyst quality rate	Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor	5-6 days