Blastocyst AI Assisted Morphokinetics in ART

NCT07611448 | Enrolling By Invitation

• 1 other identifier: VIABLE-AIM
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Infertility Assisted Reproductive Technology; Infertility (IVF Patients)

Keywords

Real-time morphokinetics; Blastocyst grading; Blastocyst morphokinetics

Outcome Measures

Primary Outcomes (1)

• Ongoing Clinical Pregnancy

  Evaluate the association between the AI assisted blastocyst Morphokinetic extracted from a 30 seconds blastocyst video recording and ongoing clinical pregnancy.

  From enrollment and embryo morphokinetic evaluation to ongoing clinical pregnancy evaluated at 12 weeks of pregnancy in pregnant patients.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll patients undergoing ART who generate at least one blastocyst on day 5, 6, or 7 of in-vitro culture. All participants will receive clinical management according to the treating physician's judgment and the established clinical and laboratory protocols of the IVF center. Participation in this observational study will not modify medical treatment, laboratory procedures, or clinical decision-making, and no additional interventions affecting patient care will be introduced. Eligibility for study participation requires a thirty-second real-time video recording. Blastocysts recorded may originate from conventional IVF or ICSI cycles, frozen-thawed embryo transfers, or embryos undergoing biopsy for PGT-A. Each recorded embryo will be appropriately coded to document developmental stage, embryo status (fresh or frozen-thawed), and genetic testing classification when available, including chromosomal designation and reported sex determination where applicable.

You may qualify if:

• Signed Inform Consent
• Ages between 18 and 45 years
• Patients using own or donated eggs
• Patients undergoing assisted reproduction procedures (ICSI with Embryo Transfer, Frozen Embryo Transfers with or without PGT-A receiving a single embryo transfer.
• Patients with at least one embryo at the blastocyst stage on day 5, day 6 or day 7 of embryo development.
• Patients using a surrogate carrier for the embryo transfer procedure.
• Patients with Abnormal Embryos after PGT-A to be discarded.
• Patients with Euploid Embryos after PGT-A to be discarded

You may not qualify if:

• Absence of viable embryos at the blastocyst stage.
• Any uterine abnormalities that could affect embryo implantation.

Sponsors & Collaborators

• Viable Biosciences: lead

Study Sites (1)

Women's Specialty & Fertility Center

Clovis, California, 93611, United States

Location

Related Publications (26)

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  BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 28, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)