Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

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

Study Overview

• Status: Completed
• Conditions: Infertility; Sperm DNA Fragmentation
• Intervention / Treatment: Other: PICSI; Other: MACS

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 Type: Interventional
• Enrollment (Actual): 515
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Maadi
    • Cairo, Maadi, Egypt, 11728
      • Ganin Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ganin Fertility Center
• Investigators: Study Director: Hosam Zaki, MSc, FRCOG, Ganin Fertility Center; Principal Investigator: Manar Hozayen, MSc., Ganin Fertility Center; Principal Investigator: Eman Hasanen, BSc., Ganin Fertility Center; Principal Investigator: Hanaa Alkhader, MBBS/MD, Ganin Fertility Center; Principal Investigator: Yara Hazem, BP, Ganin Fertility Center; Principal Investigator: Amr Elshimy, BSc., Ganin Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 6, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: PGT-A; Sperm DNA fragmentation; PICSI; MACS; Sperm selection; Euploidy rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: GFC-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No