Clinical trial NCT06602687: PICSI Impact on Euploidy in Assisted Reproduction
Official title: Sperm Hyaluronic Binding Selection (PICSI): Impact on Embryo Aneuploid Status in Assisted Human Reproduction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: PICSI
Sperm
Aneuploidy
Lead sponsor: Merrion Fertility Clinic
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 142
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Euploidy rates
timeFrame: 4 weeks
Secondary outcomes:
measure: Fertilisation rates
timeFrame: 24-48 hours
measure: Blastocyst development and rate
timeFrame: 5 and 6 days
measure: Positive hCG rate
timeFrame: 6-7 weeks
measure: Clinical pregnancy rate
timeFrame: 6-7 weeks
measure: Miscarriage rate
timeFrame: up to 22 weeks
measure: Live birth rate
timeFrame: 37-42 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Merrion Fertility Clinic
Study officials:
affiliation: Merrion Fertility Clinic and the National Maternity Hospital
name: David Crosby, MD
role: STUDY_DIRECTOR
References: