Overture Metabolomics Non-Selection Study

Infertility Clinical Trial

Official title:

Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04878991
• Other study ID #: SUB-OVL-IRB-MTB-06.01.2021
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: Overture Life
• Contact: Beatriz Maroto
• Phone: 620521878
• Email: beatriz[@]overture.life
• Is FDA regulated: No
• Study type: Observational

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.

This study will take place at multiple locations in the United States and Spain.

Description:

Patients will undergo 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. Details of sample collection and analysis are provided in Sections 6.3.1 & 6.3.2.

Single embryo transfer will be performed with the best morphology blastocyst being 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 monitored until 12 weeks of gestation at which time they will be closed from the study.

The embryo transfer outcome will be compared to MPI and MEI result to determine the NPV and PPV of metabolomics vs implantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Spain	Clinical Juana Crespo	Valencia
United States	New Hope Fertility Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Overture Life	Clinica Juana Crespo, New Hope Fertility Center

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this non-selection study are negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. PGT-A.		8 weeks after embryo transfer