Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

NCT05494216 | Completed

• 1 other identifier: GFC-005
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

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

Conditions

Sperm DNA Fragmentation; Infertility

Keywords

Sperm selection; PICSI; MACS; Sperm DNA fragmentation; PGT-A; Euploidy rate

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Fertilization rate

  1 day

• Cleavage rate

  3 days

• Blastocyst development rate

  5-6 days

• Blastocyst quality rate

  5-6 days

Study Arms (2)

PICSI

ACTIVE COMPARATOR

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

MACS

ACTIVE COMPARATOR

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

Interventions

PICSI OTHER

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

PICSI

MACS OTHER

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

MACS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganin Fertility Center: lead

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Eman Hasanen, BSc.

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Manar Hozayen, MSc.

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Amr Elshimy, BSc.

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hanaa Alkhader, MBBS/MD

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hosam Zaki, MSc, FRCOG

  Ganin Fertility Center

  STUDY DIRECTOR

• Yara Hazem, BP

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

EG (1)