Sperm Hyaluronic Binding Selection (PICSI): Impact on Embryo Aneuploid Status in Assisted Human Reproduction

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Merrion Fertility Clinic
RECRUITING
Dublin
Contact Information
Primary
Louise E Glover, PhD
lglover@merrionfertility.ie
353 + 15567900
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 142
Treatments
No_intervention: Standard ICSI
ICSI performed using standard sperm selection methods.
Experimental: PICSI
ICSI performed using sperm selected based on hyaluronan binding (PICSI® dish, Cooper Surgical).
Related Therapeutic Areas
Sponsors
Leads: Merrion Fertility Clinic

This content was sourced from clinicaltrials.gov