Targeted Metabolomics and Spent Embryo Culture Medium

Recruiting

• Conditions: Metabolomics; Embryo Culture Media

• Registration Number: NCT06094439
• Lead Sponsor: gyn-medicum Göttingen

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").

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 Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos	24 months	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 .

Trial Locations

Locations (1)

Gyn-Medicum; 🇩🇪 Göttingen, Niedersachsen, Germany