Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology

NCT02698488 | Unknown

• 1 other identifier: 201603
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryo Selection; IVF; Morphology

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy

  Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.

  3 months

Study Arms (2)

Embryo Selection by Morphology

ACTIVE COMPARATOR

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

Embryo Selection by Morphology and Mass Spectroscopy

ACTIVE COMPARATOR

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

Interventions

Morphology PROCEDURE

Embryo Selection by Morphology; Embryo Selection by Morphology and Mass Spectroscopy

Morphology and Mass Spectroscopy PROCEDURE

Embryo Selection by Morphology; Embryo Selection by Morphology and Mass Spectroscopy

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• poor response to IVF previously

Sponsors & Collaborators

• Istanbul University: lead
• Acibadem Fulya Hospital: collaborator
• Marmara University: collaborator

Study Sites (1)

Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mass Spectrometry

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ercan Bastu, M.D.

  Istanbul University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ercan Bastu, M.D.

CONTACT

+90 532 413 41 95; ercan.bastu@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)