NCT04976920

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

July 15, 2021

Last Update Submit

November 13, 2023

Conditions

Infertility

Keywords

IVFgenetic screeningpreimplantation genetic testing

Outcome Measures

Primary Outcomes (1)

  • Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.

    PPV (MEI high potential implanting / Total implanting), NPV (MEI low potential implanting / Total not implanting)

    Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks

Study Arms (1)

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.

Diagnostic Test: Overture Metabolomics Embryo Selection

Interventions

Overture Metabolomics Embryo SelectionDIAGNOSTIC_TEST

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.

Treatment Group

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited from an IVF center

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grupo Procrearte

Buenos Aires, Argentina

RECRUITING

Clinical Juana Crespo

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jose Horcajadas, PhD

    Overture Life

    PRINCIPAL INVESTIGATOR

  • Santiago Munne, PhD

    Overture Life

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Nadal

CONTACT

323-420-6343alex@overture.life

Sara Cabello

CONTACT

sara@overture.life

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 26, 2021

Study Start

July 12, 2021

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Data will be presented at industry conferences, and published in peer reviewed journals.

Locations

AR(1)ES(1)