Clinical trial NCT05494216: Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
Official title: Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sperm DNA Fragmentation
Infertility
Keywords: Sperm selection
PICSI
MACS
Sperm DNA fragmentation
PGT-A
Euploidy rate
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Euploidy rate
timeFrame: 15 days post ICSI
measure: Aneuploidy rate
timeFrame: 15 days post ICSI
measure: Low mosaic rate
timeFrame: 15 days post ICSI
measure: High mosaic rate
timeFrame: 15 days post ICSI
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Cleavage rate
timeFrame: 3 days
measure: Blastocyst development rate
timeFrame: 5-6 days
measure: Blastocyst quality rate
timeFrame: 5-6 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: Maadi
Study officials:
affiliation: Ganin Fertility Center
name: Eman Hasanen, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Manar Hozayen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Amr Elshimy, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Alkhader, MBBS/MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_DIRECTOR
affiliation: Ganin Fertility Center
name: Yara Hazem, BP
role: PRINCIPAL_INVESTIGATOR
References: