Targeted Metabolomics and Spent Embryo Culture Medium

Sponsor
gyn-medicum Göttingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT06094439
Collaborator
(none)
20
1
28
0.7

Study Details

Study Description

Brief Summary

More than 8 million babies have been born through in vitro fertilization (IVF). Non-invasive observation of embryos in vitro to better understand their development is becoming increasingly important. Morphology has been used as standard from the beginning, but has the disadvantage of subjectivity. Now the emphasis in basic and clinical research is on developing rapid, quantitative, non-invasive tests. Hence comes the idea of metabolic profiling of spent embryo culture medium (SECM) as a biomarker. This could be useful for understanding and improving the nutritional environment of oocytes and embryos. The goal of our study is to determine metabolic profiles of the SECM in combination with morphological assessments to better understand the nutritional requirements of the embryo. The goal would be to optimize media specifically, depending on patient and embryo characteristics ("personalized medicine") ("the embryo in vitro as patient").

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Following successful fertilization (day 1), each embryo will be cultured for 5-6 days (day 5-6) to form the blastocyst. Then, morphological evaluation will be performed by an expert embryologist to confirm poor and good embryo quality. At the end of the culture, 50 µl of SECM will be collected from each embryo and stored for metabolomics analysis. Samples including medium only and no embryos will be used as controls. The metabolome will be characterized in SECM samples using the respective assay targeted kit.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Targeted Metabolomics of Spent Embryo Culture Medium
    Actual Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2024
    Anticipated Study Completion Date :
    Dec 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    good or poor embryo quality

    morphological evaluation will be performed by an expert embryologist to confirm poor and good embryo quality

    metabolomics profiles

    metabolomics profiles will be performed by a Metabolomics core facility

    Outcome Measures

    Primary Outcome Measures

    1. Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos [24 months]

      Metabolomics profiles

    Secondary Outcome Measures

    1. amino acids profiles of good vs. amino acids profiles of poor quality embryos [24 months]

      amino acids profiles

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 46 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Available spent embryo culture medium (SECM) samples with Informed consent
    Exclusion Criteria:
    • Diabetes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gyn-Medicum Göttingen Niedersachsen Germany 37073

    Sponsors and Collaborators

    • gyn-medicum Göttingen

    Investigators

    • Study Chair: Andreas Schmutzler, PD Dr. med., gyn-medicum Göttingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    gyn-medicum Göttingen
    ClinicalTrials.gov Identifier:
    NCT06094439
    Other Study ID Numbers:
    • gyn-medicumGöttingen
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    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:
    No

    Study Results

    No Results Posted as of Oct 23, 2023