PICSI Impact on Euploidy in Assisted Reproduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PICSI.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sperm Hyaluronic Binding Selection (PICSI): Impact on Embryo Aneuploid Status in Assisted Human Reproduction
Overview
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.
Interventions
- Device PICSI
The PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical).
Primary outcome measures
- Euploidy rates [Time frame: 4 weeks]
Secondary outcome measures (6)
- Fertilisation rates [Time frame: 24-48 hours]
- Blastocyst development and rate [Time frame: 5 and 6 days]
- Positive hCG rate [Time frame: 6-7 weeks]
- Clinical pregnancy rate [Time frame: 6-7 weeks]
- Miscarriage rate [Time frame: up to 22 weeks]
- Live birth rate [Time frame: 37-42 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- Merrion Fertility Clinic — Dublin
Identifiers
NCT: NCT06602687 · MFC3