Targeted Metabolomics and Spent Embryo Culture Medium

Metabolomics Clinical Trial

Official title:

Targeted Metabolomics of Spent Embryo Culture Medium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094439
• Other study ID #: gyn-medicumGöttingen
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: gyn-medicum Göttingen
• Contact: Andreas Schmutzler, PD Dr. med.
• Phone: +49-551-41337
• Email: a.schmutzler[@]gyn-medicum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 46 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetes

Related Conditions & MeSH terms

• Embryo Culture Media
• Metabolomics

Locations

Country	Name	City	State
Germany	Gyn-Medicum	Göttingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
gyn-medicum Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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