Blastocyst AI Assisted Morphokinetics in ART

Part of paid clinical trials in Clovis, California.

Sponsor
Viable Biosciences
Study ID
NCT07611448
Status
Enrolling By Invitation

Conditions

  • Infertility (IVF Patients)
  • Infertility Assisted Reproductive Technology

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to learn if embryo characteristics obtained via the recording of real-time embryo activity via 30-seconds video capture (e.g.: Embryo Morphokinetics) can correlate with known embryo outcome in patients receiving In-Vitro Fertilization Treatment (IVF). Current Embryo morphology is performed with direct observation of embryo characteristics under the microscope. The observer will follow embryo grading standards based on embryo symmetry, development stage and growth pattern based on day of culture, presence of defined embryo characteristics with definition of viability to transfer into the uterus, cryopreserve for future use or discard. Today, the final embryo outcome can be correlated with the subjective embryo grading performed by the embryologist to evaluate how precise is the viability assessment of embryo characteristics and potential. This observational study attempts to create enough data to evaluate if real-time embryo morphokinetics can correlate with known outcomes. Patients participating in this study will not obtain any benefit from the recording of their embryos. They'll continue with their treatment according to the medical provider decision. Embryos will be selected using standard of care practice including: Transfer into the uterus. Cryopreservation. Biopsy for pre-implantation genetic testing and cryopreservation. Discard. The data obtained from this study will be analyzed to generate hypothesis and potentially design a prospective study where this tool can be used to aid in the embryo grading and selection process in comparison with standard of care. The study includes patients undergoing Assisted Reproductive Technologies (ART) including IVF, Intracytoplasmic Sperm Injection (ICSI), Frozen-Thawed Embryo Transfer including or not Embryos previously analyzed genetically. This includes embryos already defined as viable (genetically normal) or embryos to be discarded (genetically abnormal). What is Embryo Morphokinetics? Embryos are in constant movement with cellular activity invisible to the naked eye. Capturing a real-time video can convert that cellular movement and activity into pixels. Those pixels can be followed, and certain patterns can be observed and created. With the use of Artificial Intelligence (AI) those patterns can be identified, labelled, and analyzed to potentially be correlated with embryo outcome. It has been demonstrated, in the animal field, that embryos with certain morphokinetics patterns do not implant inside the uterus therefore not achieving a pregnancy. Also, embryos with high activity may be associated with genetic abnormality. In this study the following comparisons will be performed. Embryo Morphokinetics at the Blastocyst stage including: Blastocyst morphokinetics before cryopreservation and after thawing. Blastocyst morphokinetics before and after trophectoderm biopsy. Blastocyst morphokinetics in euploid embryos before transfer. Blastocyst morphokinetics in aneuploid embryos before discard. * Primary hypothesis: Blastocyst morphokinetics correlate with Pregnancy outcome * Secondary hypothesis: Blastocyst morphokinetics correlates with embryo recovery after thawing and after biopsy. * Tertiary hypothesis: Blastocyst morphokinetics correlates with know genetic diagnosis (euploid or aneuploid)

Key Dates

Start date
Mar 5, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patients undergoing Assisted Reproductive Technologies (ART)
    Patients meeting inclusion exclusion criteria undergoing ART. This includes In-Vitro Fertilization with embryo transfer, Frozen-Thawed embryo transfer with and without pre-implantation genetic testing. Single blastocyst to be transferred will be video recorded using conventional inverted microscope, camera and recording software during 30 seconds before embryo transfer, before and after blastocyst biopsy and after blastocyst thawing.

Primary Outcome Measure

Ongoing Clinical Pregnancy [ Time Frame: From enrollment and embryo morphokinetic evaluation to ongoing clinical pregnancy evaluated at 12 weeks of pregnancy in pregnant patients. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Women's Specialty & Fertility CenterClovisCalifornia93611-

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Women's Specialty & Fertility Center· Clovis, CA

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