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
Not provided
Not provided
Not provided
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ejaculated sperm | Active Comparator | Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm |
|
| testicular extracted sperm | Active Comparator | Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracytoplasmic sperm injection | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rates | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| sperm DNA damage | Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure | |
| oocyte fertilization rates | at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirk C. Lo, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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
Not provided
| embryo cleavage rate | Day 3 post oocytes retrieval |
| blastocyst rate | Day 5 post oocytes retrieval |
| pregnancy rate | Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound | 6 to 8 week ultrasound |
| rate of spontaneous abortion | after a clinical pregnancy has been established, up to 10 months after procedure |
| birth defects | 1-year following delivery |
| D052801 |
| Male Urogenital Diseases |
| D008919 | Investigative Techniques |