Targeted Metabolomics and Spent Embryo Culture Medium

NCT ID: NCT06094439

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Embryo Culture Media Metabolomics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

good or poor embryo quality

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

No interventions assigned to this group

metabolomics profiles

metabolomics profiles will be performed by a Metabolomics core facility

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Diabetes
Minimum Eligible Age

35 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

gyn-medicum Göttingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas Schmutzler, PD Dr. med.

Role: STUDY_CHAIR

gyn-medicum Göttingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gyn-Medicum

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andreas Schmutzler, PD Dr. med.

Role: CONTACT

+49-551-41337

Alireza Alizadeh Moghadam Masouleh, PhD

Role: CONTACT

+49-551-41337

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andreas Schmutzler, PD Dr. med.

Role: primary

0049 551 41337

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33495963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34573944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37192834 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

gyn-medicumGöttingen

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Retrospective Database Studies
NCT01219296 COMPLETED
Discarded Materials Study
NCT01219335 RECRUITING
The Role of hCG in Thawed Embryo Transfer
NCT07004192 RECRUITING PHASE4