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

Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: IVF; Embryo Selection; Morphology
• Intervention / Treatment: Procedure: Morphology; Procedure: Morphology and Mass Spectroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria

• poor response to IVF previously

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy	Clinical pregnancy will be defined as the presence of a fetal heartbeat using vaginal ultrasound at 6 weeks of amenorrhoea.	3 months

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Marmara University; Acibadem Fulya Hospital
• Investigators: Principal Investigator: Ercan Bastu, M.D., Istanbul University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 201603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No