NCT06419127

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
86mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2025Jun 2033

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2033

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

6.4 years

First QC Date

May 14, 2024

Last Update Submit

January 27, 2026

Conditions

Infertility, FemaleInfertility, MaleInfertilityIVFAneuploidy

Keywords

ivfinfertilitypgtembryo

Outcome Measures

Primary Outcomes (16)

  • 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

  • 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

Study Arms (1)

Infertile patients

Infertile patients undergoing IVF with PGT.

Diagnostic Test: Timelapse incubation and PGT

Interventions

Timelapse incubation and PGTDIAGNOSTIC_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.

Infertile patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All infertile patients undergoing IVF with PGT

You may qualify if:

  • all patients undergoing IVF with PGT

You may not qualify if:

  • patients undergoing IVF and not electing for PGT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gattaca Genomics

Fort Lauderdale, Florida, 33308, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Infertility, FemaleInfertility, MaleInfertilityAneuploidyLong Qt Syndrome 3

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2033

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data will not be shared with other researchers

Locations

US(1)