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The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results.
Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.
Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer.
To date, no one has combined the data from both tools to try to advance the IVF field.
Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infertile patients | Infertile patients undergoing IVF with PGT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timelapse incubation and PGT | Diagnostic Test | Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first cleavage | time of embryo to undergo first cleavage | 24 hours |
| Time to blastulation | time of embryo to form a blastocoel | 5-7 days |
| Fertilization morphology | the morphological appearance of the pronuclei | 24 hours |
| Embryo morphology | the morphological appearance of the embryos | 2-7 days |
| Patient age | Patient age | 0 days |
| Partner age | Partner age | 0 days |
| Partner diagnosis | Partner diagnosis | 0 days |
| Metabolomics of culture media | measurement of the spent culture media for amino acids, enzymes, and metabolites | 7 days |
| AMH | antimullerian hormone level in female's blood | 0 days |
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Inclusion Criteria:
Exclusion Criteria:
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All infertile patients undergoing IVF with PGT
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gattaca Genomics | Fort Lauderdale | Florida | 33308 | United States |
Data will not be shared with other researchers
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The piece of the embryo that is utilized for PGT will be amplified, analyzed, and maintained according to standard operating procedures.
| Days of stimulation | the number of days the patient underwent stimulation for IVF | 0-15 days |
| Dosage of stimulation meds | the amount of stimulation meds the patient took during IVF treatment | 0-15 days |
| Pregnancy | initial bhCG levels | 2 weeks after transfer |
| Patient diagnosis | Number of patients with each specific diagnosis, including low ovarian reserve, PCOS, primary infertility, secondary infertility, endometrosis, and unknown infertility. | 0 days |
| implantation | Number of patients that develope a sac within the uterus post transfer | 4 weeks post transfer |
| fetal cardiac heartbeat | Number of patients that develop a fetal cardiac heartbeat after transfer | 6 weeks |
| livebirth | Number of patients that have a livebirth of an infant after IVF | approximately 9 months after transfer |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007248 | Infertility, Male |
| D007246 | Infertility |
| D000782 | Aneuploidy |
| C565840 | Long Qt Syndrome 3 |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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