Metabolomics Non Selection Study - Vitrolife Media

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    205
  • sponsor
    Overture Life
Updated on 6 August 2021
embryo transfer
embryo culture

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.

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.

Details
Condition Female Genital Diseases, Infertility, sterility, unable to conceive
Treatment Overture Metabolomics Embryo Selection
Clinical Study IdentifierNCT04976920
SponsorOverture Life
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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