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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
Sponsor:
Collaborators:
Acibadem Fulya Hospital
Marmara University
Information provided by (Responsible Party):
Ercan Bastu, Istanbul University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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

Arm Intervention/treatment
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
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
Procedure: Morphology and Mass Spectroscopy



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any infertility etiology
  • good previous response to IVF with ≥1 embryo

Exclusion Criteria

  • poor response to IVF previously

Information from the National Library of Medicine

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


Contacts
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Contact: Ercan Bastu, M.D. +90 532 413 41 95 ercan.bastu@istanbul.edu.tr

Locations
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Turkey
Istanbul University School of Medicine
Istanbul, Turkey, 34093
Contact: Ercan Bastu, M.D.    +90 532 413 41 95    ercan.bastu@istanbul.edu.tr   
Principal Investigator: Ercan Bastu, M.D.         
Sponsors and Collaborators
Istanbul University
Acibadem Fulya Hospital
Marmara University
Investigators
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Principal Investigator: Ercan Bastu, M.D. Istanbul University School of Medicine
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Responsible Party: Ercan Bastu, Associate Professor of Obstetrics and Gynecology, Istanbul University
ClinicalTrials.gov Identifier: NCT02698488    
Other Study ID Numbers: 201603
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No