PICSI Impact on Euploidy in Assisted Reproduction

Merrion Fertility Clinic

Status: Enrolling

Conditions: Infertility

Treatments: Device: PICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT06602687

MFC3

Details and patient eligibility

About

Hyaluronic acid (HA) is a major component of the cumulus complex surrounding oocytes. Intracytoplasmic sperm injection (ICSI) involves injection of a selected sperm into the oocyte. Embryologists select sperm with normal morphology and progressive motility. Physiologic intracytoplasmic sperm injection (PICSI) involves sperm selection for ICSI based on hyaluronan binding. Mature sperm which bind to HA have greater genomic integrity and reduced levels of DNA fragmentation. Earlier observational studies demonstrated improved outcomes in assisted reproductive technologies (ART) including improved clinical pregnancy rates, decreased miscarriage rates and higher live birth rates. A large multicentre randomized trial, the HABSelect trial, which included over 2,500 couples, found that PICSI did not improve term (>37 weeks gestation) live birth rates compared to standard ICSI. However, mechanistic analysis of the data from the HABSelect trial showed a significant reduction in miscarriage rates, most notable in couples where the woman was aged over 37 years where a significant reduction in miscarriage rate was seen (40% with ICSI vs 15% with PICSI). A 2021 retrospective sibling oocyte study, including 45 cycles, compared fertilisation and embryo development and found higher fertilisation rate in PICSI cycles. No difference was observed in clinical pregnancy rates; miscarriage rates and live birth rates were not reported. We aim to prospectively study PICSI vs standard ICSI in sibling oocytes to investigate if PICSI improves embryological and ART outcomes, particularly fertilisation rate, embryo euploid status and miscarriage rate, where the female patient is aged over 35 years.

Enrollment: 142 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couples undergoing a planned ICSI-PGT-A cycle using their own fresh gametes
• Female age > 35 years and/or Male age > 40 years
• Minimum of two mature eggs at time of egg maturity assessment

Exclusion criteria

• Couples undergoing a planned IVF cycle (even if converted to ICSI)
• Patients using donor gametes for an ICSI cycle
• Patients using frozen gametes for an ICSI cycle

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Standard ICSI

No Intervention group

Description:

ICSI performed using standard sperm selection methods.

PICSI

Experimental group

Description:

ICSI performed using sperm selected based on hyaluronan binding (PICSI® dish, Cooper Surgical).

Treatment:

Device: PICSI