Recruiting

Metabolomics

Sponsor:

Overture Life

Code:

NCT04878991

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Overture Metabolomics Embryo Selection

Study Details

Brief 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.

Conditions

Infertility

Study ID

NCT04878991

Start date

May 5, 2021

Status verified date

Nov, 2023

Completion date

Jan 30, 2024

Anticipated

Primary completion date

Jan 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

At the time of initial visit:

  • Require or request PGT of any kind
  • Low ovarian reserve defined as follicle stimulating hormone (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (AMH) <15 pmol/L (or <2 ng/ml) within prior 12 months of cycle start

At the time of embryo selection:

-Patients without at least one embryo to transfer.

Study Design

Enrollment

410 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • The primary endpoint of this non-selection study are negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. PGT-A. [ Time Frame: 8 weeks after embryo transfer ]

Central Contacts and Locations

Central contacts

Beatriz Maroto

620521878beatriz@overture.life

Sara Cabello

sara@overture.life

Locations

New Hope Fertility Center

Recruiting

New York, New York, United States, 10019

Contacts

Meryem Guler

metabolomics@nhfc.com

More Information

Sponsor

Overture Life

Last update posted

Nov 14, 2023

Last verified

Nov, 2023

Keywords

  • IVF
  • genetic screening
  • preimplantation genetic testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Overture Life on 2023-11-14.