Targeted Metabolomics and Spent Embryo Culture Medium

NCT06094439 | Unknown

• 1 other identifier: gyn-medicumGöttingen
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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").

Conditions

Embryo Culture Media; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos

  The metabolome will be characterized in SECM samples of good and poor quality embryos using the respective assay kit. This method needs to be developed and analyses are planned in cooperation with the metabolomics core facility; the targeted metabolomics approach using the MxP® Quant 500 kit assay (BIOCRATES Life Sciences AG, Innsbruck, Austria) will be used. The kit plates are used for the quantification of amino acids, acylcarnitines, sphingomyelins, phosphatidylcholines, hexoses, and biogenic amines in SECM of good and poor quality embryos. Results of metabolic set enrichment analysis (MSEA) and metabolic pathway analysis (MetPA) will be used as the final results to compare the metabolite profiles of good and poor quality embryos .

  24 months

Study Arms (2)

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

Eligibility Criteria

• Age: 35 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The available spent embryo culture medium (SECM) samples (n\> 50 samples) will be collected from embryos produced by IVF and ICSI during nine months. The experimental groups will include: I) SECM obtained from good quality embryos and II) SECM obtained from poor quality embryos. In this study, the samples are classified according to their morphological characteristics of embryos, BMI and age of the women.

You may qualify if:

• \- Available spent embryo culture medium (SECM) samples with Informed consent

You may not qualify if:

• Diabetes

Sponsors & Collaborators

• gyn-medicum Göttingen: lead

Study Sites (1)

Gyn-Medicum

Göttingen, Lower Saxony, 37073, Germany

RECRUITING

Related Publications (3)

• Inoue N, Nishida Y, Harada E, Sakai K, Narahara H. GC-MS/MS analysis of metabolites derived from a single human blastocyst. Metabolomics. 2021 Jan 25;17(2):17. doi: 10.1007/s11306-021-01770-x.

  PMID: 33495963 BACKGROUND

• Siristatidis C, Dafopoulos K, Papapanou M, Stavros S, Pouliakis A, Eleftheriades A, Sidiropoulou T, Vlahos N. Why Has Metabolomics So Far Not Managed to Efficiently Contribute to the Improvement of Assisted Reproduction Outcomes? The Answer through a Review of the Best Available Current Evidence. Diagnostics (Basel). 2021 Sep 2;11(9):1602. doi: 10.3390/diagnostics11091602.

  PMID: 34573944 BACKGROUND

• Cimadomo D, Rienzi L, Conforti A, Forman E, Canosa S, Innocenti F, Poli M, Hynes J, Gemmell L, Vaiarelli A, Alviggi C, Ubaldi FM, Capalbo A. Opening the black box: why do euploid blastocysts fail to implant? A systematic review and meta-analysis. Hum Reprod Update. 2023 Sep 5;29(5):570-633. doi: 10.1093/humupd/dmad010.

  PMID: 37192834 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

50 µl of spent embryo culture media

Study Officials

• Andreas Schmutzler, PD Dr. med.

  gyn-medicum Göttingen

  STUDY CHAIR

Central Study Contacts

Andreas Schmutzler, PD Dr. med.

CONTACT

+49-551-41337; a.schmutzler@gyn-medicum.de

Alireza Alizadeh Moghadam Masouleh, PhD

CONTACT

+49-551-41337; a.alizadeh@gyn-medicum.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)