Clinical trial NCT04878991: Overture Metabolomics Non-Selection Study
Official title: Non-Selection Trial Comparing Metabolomics to Morphology Embryo Selection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: IVF
genetic screening
preimplantation genetic testing
Lead sponsor: Overture Life
Sponsor class: INDUSTRY
Collaborators: name: New Hope Fertility Center
name: Clinica Juana Crespo
First posted: 2021-05-10
Enrollment: 410
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from an IVF center

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint of this non-selection study are negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. PGT-A.
timeFrame: 8 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New Hope Fertility Center
state: New York
city: Valencia
country: Spain
facility: Clinical Juana Crespo
Study officials:
affiliation: Overture Life
name: Jose Horcajadas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Overture Life
name: Santiago Munne, PhD
role: PRINCIPAL_INVESTIGATOR
References: