Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology
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|ClinicalTrials.gov Identifier: NCT02698488|
Recruitment Status : Unknown
Verified August 2016 by Ercan Bastu, Istanbul University.
Recruitment status was: Not yet recruiting
First Posted : March 3, 2016
Last Update Posted : August 30, 2016
Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The optimal scenario is the transfer of a single embryo which gives rise to a singleton pregnancy. The current limitations in determination of embryos that have the highest implantation potential probably contribute to the low rates of pregnancy during IVF treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a 'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it provides a chance to evaluate them from the oocyte stage all the way to the blastocysts stage. Hence, in the first era of IVF, there were number of studies that evaluated this parameter and associated morphology with IVF success rates. On the other hand, it has been previously stated that the slight increase in pregnancy rates during IVF treatment is mostly likely a result of better practices in laboratory than morphological evaluation. Due to the limitations of morphological evaluation, several researchers have investigated adjunctive non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.
Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples needed minimal preparation; analytical analysis was rapid and large amounts of data was available. Hence, MS might be a promising approach for metabolomic profiling of embryo culture media.
|Condition or disease||Intervention/treatment||Phase|
|Embryo Selection IVF Morphology||Procedure: Morphology Procedure: Morphology and Mass Spectroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Embryo Selection by Morphology
Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study
Procedure: Morphology and Mass Spectroscopy
Active Comparator: Embryo Selection by Morphology and Mass Spectroscopy
Embryos will be morphologically evaluated according to the number and regularity of blastomeres and fragmentation degree. Only embryo culture media of good quality embryos (embryos with ≥6 cells with no fragmentation) will be included in the study. After dilution, embryo culture media will be analyzed by electrospray ionization quadrupole time-of-flight (ESI-QTOF) MS. The spectra will be collected in the negative ion mode. Abundance of ions in each spectrum will be further analyzed.
Procedure: Morphology and Mass Spectroscopy
- Clinical Pregnancy [ Time Frame: 3 months ]Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698488
|Contact: Ercan Bastu, M.D.||+90 532 413 41 firstname.lastname@example.org|
|Istanbul University School of Medicine|
|Istanbul, Turkey, 34093|
|Contact: Ercan Bastu, M.D. +90 532 413 41 95 email@example.com|
|Principal Investigator: Ercan Bastu, M.D.|
|Principal Investigator:||Ercan Bastu, M.D.||Istanbul University School of Medicine|