PICSI Impact on Euploidy in Assisted Reproduction

NCT ID: NCT06602687

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2029-01-01

Brief 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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard ICSI

ICSI performed using standard sperm selection methods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PICSI

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

Group Type: EXPERIMENTAL

PICSI

Intervention Type: DEVICE

The PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical).

Interventions

PICSI

The PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merrion Fertility Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crosby, MD

Role: STUDY_DIRECTOR

Merrion Fertility Clinic and the National Maternity Hospital

Locations

Merrion Fertility Clinic

Dublin, Dublin, Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Louise E Glover, PhD

Role: CONTACT

lglover@merrionfertility.ie

353 + 15567900

Facility Contacts

Louise E Glover, PhD

Role: primary

lglover@merrionfertility.ie

353 + 15567900

David Crosby, MD

Role: backup

Louise Glover, PhD

Role: backup

Sarah Petch, MD

Role: backup

Other Identifiers

MFC3

Identifier Type: -

Identifier Source: org_study_id