Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality

Assessment of the quality of follicular fluid and early embryo via chemical markers.

Study Overview

• Status: Unknown
• Conditions: Infertility/Sterility

Detailed Description

The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed

• Study Type: Observational
• Enrollment (Anticipated): 220

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients undergoing IVF procedures at Carmel Medical Center

Description

Inclusion Criteria:

• Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form.
• Female patients age 18-45

Exclusion Criteria:

• Women with any malignancy
• Patient's request to be withdrawn from the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
High and low grade embryos; The distribution for the high and low grade embryos is based on common morphological grading criteria.
High and low quality follicles; The distribution for the high and low grade oocytes is based on common morphological grading criteria and on different features of the participants such as age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Different markers discriminating the studied groups.	High correlation between the studied markers and the currently used morphological assessment of the quality of embryos and oocytes will define the potential of the studied markers as a mean for embryo and quality assessment. The current study is pioneer in the field of assessment of embryos and follicles and this group of markers have not been studied previously, therefore we prefer not to clarify more details	two years

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Martha Direnfeld, Prof., Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CMC-16-0163-CTIL

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No