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

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: t
View:

• Women of any age, 25% of patients \<35 years, 25% of patients 35-37, 25% of patients 38-40, and 25% of patients \>40 years.

• Signed Subject Consent Form. No inferior limit on number of eggs

Locations
Other Locations
Argentina
Grupo Procrearte
RECRUITING
Buenos Aires
Spain
Clinical Juana Crespo
RECRUITING
Valencia
Contact Information
Primary
Alexander Nadal
alex@overture.life
323-420-6343
Backup
Sara Cabello
sara@overture.life
Time Frame
Start Date: 2021-07-12
Estimated Completion Date: 2024-01-30
Participants
Target number of participants: 205
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 New Hope 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: Clinica Juana Crespo, Grupo Procrearte

This content was sourced from clinicaltrials.gov