Clinical trial NCT04976920: Metabolomics Non Selection Study - Vitrolife Media
Official title: Non-selection Trial Comparing Metabolomics to PGT-A Embryo Selection Using Vitrolife G-TL Media
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Keywords: IVF
genetic screening
preimplantation genetic testing
Lead sponsor: Overture Life
Sponsor class: INDUSTRY
Collaborators: name: Clinica Juana Crespo
name: Grupo Procrearte
First posted: 2021-07-26
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
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.

Detailed description: 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.

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 closed out of the study at this time.

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

Eligibility criteria: Inclusion Criteria:

* 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

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: Negative predictive value (NPV) and positive predictive value (PPV) for MEI vs. expected implantation based solely on morphology.
timeFrame: Approximately 4-5 months, inclusive of IVF cycle, embryo transfer and monitoring up to eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Grupo Procrearte
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: