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Metabolomics Non Selection Study - Vitrolife Media

Infertility Clinical Trial

Official title:
Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media

Clinical Trial 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.

Clinical Trial Description

Patients will undergo a routine IVF cycle. This will include 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. For the embryo transfer, the best morphology blastocyst will be 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 closed out of the study at this time. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04976920
Study type Observational
Source Overture Life
Contact Alexander Nadal
Phone 323-420-6343
Email alex@overture.life
Status Recruiting
Phase
Start date July 12, 2021
Completion date January 30, 2024
View Details
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