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 research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embryo Culture medium | Experimental | Embryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embryo Culture medium | Device | Two step sequential embryo culture medium system |
|
| Measure | Description | Time Frame |
|---|---|---|
| embryo development | Blastocyst development and quality on days 5 and 6 of culture | 7 days after egg retrieval |
| pregnancy rate | The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination. | 2 months after egg retrieval |
| offspring weight | The birth weight of children born | 1 year after egg retrieval |
| offspring gender | The gender of children born | 1 year after egg retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| fertilization | the percentage of mature eggs that successfully fertilized normally | 2 days after egg retrieval |
| euploid embryos | For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca L Krisher, PhD | NFFR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Laboratories of Colorado | Lone Tree | Colorado | 80124 | United States | ||
| National Fooundation for Fertility Research |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 month after egg retrieval |
| Lone Tree |
| Colorado |
| 80124 |
| United States |