Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• Women of any age, including egg donors. 50% will be \<35 and the rest 35 and older.
• Signed Subject Consent Form. No inferior limit on number of eggs
Locations
United States
New York
New Hope Fertility Center
RECRUITING
New York
Other Locations
Spain
Clinical Juana Crespo
RECRUITING
Valencia
Contact Information
Primary
Beatriz Maroto
beatriz@overture.life
620521878
Backup
Sara Cabello
sara@overture.life
Time Frame
Start Date: 2021-05-05
Estimated Completion Date: 2024-01-30
Participants
Target number of participants: 410
Treatments
Treatment Group
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 study embryologist. The embryo transfer outcome will be compared to the Metabolomics result to determine the NPV and PPV of Metabolomics vs implantation.
Related Therapeutic Areas
Sponsors
Leads: Overture Life
Collaborators: New Hope Fertility Center, Clinica Juana Crespo