## Protocol Section
### Identification Module
**NCT ID:** NCT06419127

**Brief Title:** Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

**Official Title:** Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

#### Organization Study ID Info
**ID:** GG1001
#### Organization
**Class:** INDUSTRY
**Full Name:** Gattaca Genomics
### Status Module
#### Completion Date
**Date:** 2029-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Gattaca Genomics

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Infertility, Female

- Infertility, Male

- Infertility

- IVF

- Aneuploidy

**Keywords:**

- ivf

- infertility

- pgt

- embryo

### Design Module

#### Bio Spec

**Description:** The piece of the embryo that is utilized for PGT will be amplified, analyzed, and maintained according to standard operating procedures.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Infertile patients undergoing IVF with PGT.

**Intervention Names:**

- Diagnostic Test: Timelapse incubation and PGT

**Label:** Infertile patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Infertile patients

**Description:** Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation.

**Name:** Timelapse incubation and PGT

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** time of embryo to undergo first cleavage

**Measure:** Time to first cleavage

**Time Frame:** 24 hours

**Description:** time of embryo to form a blastocoel

**Measure:** Time to blastulation

**Time Frame:** 5-7 days

**Description:** the morphological appearance of the pronuclei

**Measure:** Fertilization morphology

**Time Frame:** 24 hours

**Description:** the morphological appearance of the embryos

**Measure:** Embryo morphology

**Time Frame:** 2-7 days

**Description:** Patient age

**Measure:** Patient age

**Time Frame:** 0 days

**Description:** Partner age

**Measure:** Partner age

**Time Frame:** 0 days

**Description:** Patient diagnosis

**Measure:** Patient diagnosis

**Time Frame:** 0 days

**Description:** Partner diagnosis

**Measure:** Partner diagnosis

**Time Frame:** 0 days

**Description:** measurement of the spent culture media for amino acids, enzymes, and metabolites

**Measure:** Metabolomics of culture media

**Time Frame:** 7 days

**Description:** antimullerian hormone level in female's blood

**Measure:** AMH

**Time Frame:** 0 days

**Description:** the number of days the patient underwent stimulation for IVF

**Measure:** Days of stimulation

**Time Frame:** 0-15 days

**Description:** the amount of stimulation meds the patient took during IVF treatment

**Measure:** Dosage of stimulation meds

**Time Frame:** 0-15 days

**Description:** initial bhCG levels

**Measure:** Pregnancy

**Time Frame:** 2 weeks after transfer

**Description:** development of a sac within the uterus post transfer

**Measure:** implantation

**Time Frame:** 4 weeks post transfer

**Description:** development of fetal cardiac heartbeat after transfer

**Measure:** fetal cardiac heartbeat

**Time Frame:** 6 weeks

**Description:** the livebirth of an infant after IVF

**Measure:** livebirth

**Time Frame:** approximately 9 months after transfer

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* all patients undergoing IVF with PGT

Exclusion Criteria:

* patients undergoing IVF and not electing for PGT

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** All infertile patients undergoing IVF with PGT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tyl.taylor@gattacagenomics.com

**Name:** Tyl H taylor

**Phone:** 9806130105

**Role:** CONTACT

**Contact 2:**

**Email:** tyltaylor@gmail.com

**Name:** Tyl H taylor

**Phone:** 9806130105

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fort Lauderdale

**Contacts:**

***Contact 1:***

- **Email:** tyl.taylor@gattacagenomics.com

- **Name:** Tyl H taylor

- **Phone:** 980-613-0105

- **Role:** CONTACT

***Contact 2:***

- **Email:** tyltaylor@gmail.com

- **Phone Ext:** taylor

- **Role:** CONTACT

***Contact 3:***

- **Name:** Tyl H taylor, PhD, HCLD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Gattaca Genomics

**State:** Florida

**Status:** RECRUITING

**Zip:** 33308

### IPD Sharing Statement Module

**Description:** Data will not be shared with other researchers

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000002869

- Term: Chromosome Aberrations

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M10291

- Name: Infertility, Female

- Relevance: HIGH

- As Found: Infertility, Female

- ID: M10292

- Name: Infertility, Male

- Relevance: HIGH

- As Found: Infertility, Male

- ID: M4112

- Name: Aneuploidy

- Relevance: HIGH

- As Found: Aneuploidy

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M6109

- Name: Chromosome Aberrations

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

- ID: D000007247

- Term: Infertility, Female

- ID: D000007248

- Term: Infertility, Male

- ID: D000000782

- Term: Aneuploidy

### Misc Info Module

- Version Holder: 2024-05-31
