Infertility
Conditions
Keywords
PICSI, Sperm, Aneuploidy
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.
Interventions
DEVICEPICSI
The PICSI® dish is a CE marked medical device containing dots of a HA hydrogel (Cooper Surgical).
Sponsors
Merrion Fertility Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Euploidy rates | 4 weeks | Primary outcome is rate of euploid embryos per cycle after preimplantation genetic testing for aneuploidy (PGT-A) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Fertilisation rates | 24-48 hours | Defined as number of 2PNs per oocyte injected |
| 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 |
| 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. |
Countries
Ireland
Contacts
Primary ContactLouise E Glover, PhD
Outcome results
None listed