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OpenTrials
Completed

NCT Number: NCT05494216

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

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Key information

Conditions

Sperm DNA Fragmentation Genital Diseases Infertility Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PICSI

Other

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

MACS

Other

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

Primary outcomes

  1. Euploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of euploid blastocysts

  2. Aneuploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of aneuploid blastocysts

  3. Low mosaic rate

    Time frame: 15 days post ICSI

    Defined as the proportion of low mosaic blastocysts

  4. High mosaic rate

    Time frame: 15 days post ICSI

    Defined as the proportion of high mosaic blastocysts

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day

    Defined as the proportion of fertilizaed oocytes

  2. Cleavage rate

    Time frame: 3 days

    Defined as the proportion of cleaved embryos on day 3

  3. Blastocyst development rate

    Time frame: 5-6 days

    Defined as the proportion of blastocysts formed on day 5 or 6

  4. Blastocyst quality rate

    Time frame: 5-6 days

    Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2022
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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