Clinical trial NCT06094439: Targeted Metabolomics and Spent Embryo Culture Medium
Official title: Targeted Metabolomics of Spent Embryo Culture Medium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Embryo Culture Media
Metabolomics
Lead sponsor: gyn-medicum Göttingen
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: Metabolomics profiles of good vs. Metabolomics profiles of poor quality embryos
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Gyn-Medicum
state: Niedersachsen
Study officials:
affiliation: gyn-medicum Göttingen
name: Andreas Schmutzler, PD Dr. med.
role: STUDY_CHAIR
References:
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.
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.
citation: 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.