Not provided
Not provided
Not provided
Not provided
Not provided
The study was halted prior to enrollment of first participant due to non funding and recourses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.
Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system.
Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage.
G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6.
C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care.
C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global vs. G-TL Media | Experimental | Global medium will be compared with G-TL (Time-Lapse) medium. |
|
| Global vs. Cornell's C3 Media | Experimental | Global medium will be compared with Cornell's C3 single step medium. |
|
| Global vs. Cornell's sequential Media | Experimental | Global medium will be compared with Cornell's C1/C2 sequential medium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media | Biological | A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Embryo development | Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups. | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | The ratio of embryo implantation measured through ultrasound | 4 weeks |
| Pregnancy rate | The ratio of pregnancy measured through βHCG |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Maternal age- 40 years of age or younger Paternal age- 65 years of age or younger
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nikica Zaninovic, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproductive Medicine | New York | New York | 10065 | 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
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 weeks |