Overture Metabolomics Non-Selection Study

• Sponsor: Overture Life (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04878991
• Collaborator: New Hope Fertility Center (Other), Clinica Juana Crespo (Other)
• Enrollment: 410
• Locations: 2
• Anticipated Duration (Months): 19.8
• Patients Per Site: 205
• Patients Per Site Per Month: 10.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Diagnostic Test: Overture Metabolomics Embryo Selection

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 410 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection
• Actual Study Start Date: May 5, 2021
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Hope Fertility Center	New York	New York	United States	10019
2	Clinical Juana Crespo	Valencia		Spain

Sponsors and Collaborators

• Overture Life
• New Hope Fertility Center
• Clinica Juana Crespo

Investigators

• Principal Investigator: Jose Horcajadas, PhD, Overture Life
• Principal Investigator: Santiago Munne, PhD, Overture Life

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Jose Horcajadas, Principal Investigator, Overture Life
• ClinicalTrials.gov Identifier: NCT04878991
• Other Study ID Numbers: SUB-OVL-IRB-MTB-06.01.2021
• First Posted: May 10, 2021
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Dr. Jose Horcajadas, Principal Investigator, Overture Life: IVF; genetic screening; preimplantation genetic testing
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of May 31, 2022