PICSI Impact on Euploidy in Assisted Reproduction

NCT06602687 — Not applicable, Recruiting, 142 participants, Merrion Fertility Clinic

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06602687
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	142 (Estimated)
Sponsor	Merrion Fertility Clinic (Other)
Conditions	Infertility
Interventions	PICSI (Device)
Dates	start 2024-01-01, primary completion 2026-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2024-09-19, last updated 2024-09-19
Locations	1 site in Ireland

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Standard ICSI	No intervention		ICSI performed using standard sperm selection methods.
PICSI	Experimental	Device: PICSI	ICSI performed using sperm selected based on hyaluronan binding (PICSI® dish, Cooper Surgical).

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

+Outcome measures

Primary outcomes

Euploidy rates [4 weeks]: Primary outcome is rate of euploid embryos per cycle after preimplantation genetic testing for aneuploidy (PGT-A)

Secondary outcomes

Fertilisation rates [24-48 hours]: Defined as number of 2PNs per oocyte injected
Blastocyst development and rate [5 and 6 days]: Assessed on day 5 and day 6 according to Gardner grading system.
Positive hCG rate [6-7 weeks]: Defined as detection of urinary human chorionic gonadotropin (hCG) per embryo transfer cycles.
Clinical pregnancy rate [6-7 weeks]: Defined as number of fetal heartbeats/ gestational sacs identified by ultrasonographic visualisation at 6-7 weeks gestation per cycles started, oocyte retrievals or embryo transfer cycles.
Miscarriage rate [up to 22 weeks]: Defined as number of spontaneous losses of an intra-uterine pregnancy prior to 22 completed weeks of gestational age per embryo transfer cycles.
Live birth rate [37-42 weeks]: Defined as number of live births at ≥37 weeks gestation per embryo transfer cycles

+Eligibility

Sex: All, ages: 35 Years to any

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

+Locations (1)

Facility	City	Country	Status
Merrion Fertility Clinic	Dublin, Dublin	Ireland	Recruiting

+Investigators

David Crosby, MD, Study director, Merrion Fertility Clinic and the National Maternity Hospital