Infertility
Conditions
Keywords
Intracytoplasmic Sperm Injection Procedure, ICSI
Brief summary
This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.
Detailed description
In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.
Interventions
OTHERZona Pellucida-Bound Sperm Selection for ICSI
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte.
OTHERRoutine Embryologist Selected Sperm
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine.
Sponsors
IVI America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing their first in vitro fertilization (IVF) cycle * Electing single embryo transfer * Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos * Female partners age \<42 years old at start of vaginal oocyte retrieval cycle, but \>18 years old. * Normal ovarian reserve: * Antimullerian hormone level (AMH) ≥ 1.2 ng/mL * Antral follicle count (AFC) ≥ 8 * At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize * At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure * Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
Exclusion criteria
* Contraindication to IVF * Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis) * Male partner with azoospermia or oligozoospermia (\<100,000 total motile spermatozoa) * Male partner with Y-chromosome microdeletion * Male partner with any Karyotype other than 46,XY * Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures * Uncorrected hydrosalpinges that communicate with the endometrial cavity * Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid * Donor oocyte cycles * Gestational carriers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation Rate | one week after the vaginal oocyte retrieval and ICSI procedure | Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization Rate | 24 hours post ICSI procedure | fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI. |
| Blastocyst Ploidy Rate | Approximately 2 weeks after trophectoderm biopsy | Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups |
| Sustained Implantation Rates | Approximately 6 weeks after frozen embryo transfer procedure | The number of participants discharged at 8-9 weeks gestational age to their obstetrician. |
Countries
United States
Outcome results
None listed