Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP Bound Sperm Selection Oocyte Cohort | Experimental | This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure with sperm that has bound to the ZP of an immature oocyte. |
|
| Routine Care: Embryologist Selected Sperm Oocyte Cohort | Other | This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure per routine with sperm that is subjectively selected by the embryologist (based on morphology and mobility characteristics). This is the current standard of care for ICSI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zona Pellucida-Bound Sperm Selection for ICSI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate | Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI. | one week after the vaginal oocyte retrieval and ICSI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Rate | fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI. | 24 hours post ICSI procedure |
| Blastocyst Ploidy Rate | Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of Northern California | San Francisco | California | 94105 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine Embryologist Selected Sperm | Other | 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. |
|
| Approximately 2 weeks after trophectoderm biopsy |
| Sustained Implantation Rates | The number of participants discharged at 8-9 weeks gestational age to their obstetrician. | Approximately 6 weeks after frozen embryo transfer procedure |
| D008919 | Investigative Techniques |