NCT04878991

Overture Metabolomics Non-Selection Study

Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 410 (estimated)
• Sponsor: Overture Life · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo. This study will take place at multiple locations in the United States and Spain.

Detailed description

Patients will undergo ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (ICSI). All fertilized oocytes will be cultured up to blastocyst for five to six days. Spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. The spent culture media will be sent to a lab for metabolomic analysis. Details of sample collection and analysis are provided in Sections 6.3.1 \& 6.3.2. Single embryo transfer will be performed with the best morphology blastocyst being selected for transfer by the New Hope embryologist. Approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. Should the test be negative, they will be closed out of the study. Should the test be positive, they will continue to be monitored. The patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. The outcome will be documented, and the patient monitored until 12 weeks of gestation at which time they will be closed from the study. The embryo transfer outcome will be compared to MPI and MEI result to determine the NPV and PPV of metabolomics vs implantation.

Conditions

• Infertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Overture Metabolomics Embryo Selection	Patients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.

Timeline

• Start date: 2021-05-05
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2021-05-10
• Last updated: 2023-11-14

Locations

2 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study