PICSI Impact on Euploidy in Assisted Reproduction

NCT06602687 | Recruiting

• 1 other identifier: MFC3
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

PICSI; Sperm; Aneuploidy

Outcome Measures

Primary Outcomes (1)

• Euploidy rates

  Primary outcome is rate of euploid embryos per cycle after preimplantation genetic testing for aneuploidy (PGT-A)

  4 weeks

Secondary Outcomes (6)

• Fertilisation rates

  24-48 hours

• Blastocyst development and rate

  5 and 6 days

• Positive hCG rate

  6-7 weeks

• Clinical pregnancy rate

  6-7 weeks

• Miscarriage rate

  up to 22 weeks

Study Arms (2)

Standard ICSI

NO INTERVENTION

ICSI performed using standard sperm selection methods.

PICSI

EXPERIMENTAL

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

Device: PICSI

Interventions

PICSI DEVICE

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

PICSI

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merrion Fertility Clinic: lead

Study Sites (1)

Merrion Fertility Clinic

Dublin, Dublin, D02 NH93, Ireland

RECRUITING

MeSH Terms

Conditions

Infertility; Aneuploidy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crosby, MD

  Merrion Fertility Clinic and the National Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Louise E Glover, PhD

CONTACT

353 + 15567900; lglover@merrionfertility.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)