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

• ClinicalTrials.gov Identifier: NCT03350009
• Recruitment Status: Unknown
• First Posted: November 22, 2017
• Last Update Posted: January 31, 2019
• Sponsor: Carmel Medical Center
• Information provided by (Responsible Party): Carmel Medical Center

Study Description

Brief Summary:

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

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 220 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
• Actual Study Start Date: December 11, 2017
• Estimated Primary Completion Date: June 2019
• Estimated Study Completion Date: November 2019

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Different markers discriminating the studied groups. [ Time Frame: two years ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Participants are female patients undergoing IVF procedure in the IVF department in Carmel MC
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Patients undergoing IVF procedures at Carmel Medical Center

Criteria

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.

Contacts and Locations

Locations

Israel

Carmel Medical Center

Haifa, Israel, 34362

Sponsors and Collaborators

Carmel Medical Center

Investigators

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

More Information

• Responsible Party: Carmel Medical Center
• ClinicalTrials.gov Identifier: NCT03350009
• Other Study ID Numbers: CMC-16-0163-CTIL
• First Posted: November 22, 2017
• Last Update Posted: January 31, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infertility