NCT03350009

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

November 2, 2017

Last Update Submit

January 30, 2019

Conditions

Infertility/Sterility

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants are female patients undergoing IVF procedure in the IVF department in Carmel MC
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing IVF procedures at Carmel Medical Center

You may qualify if:

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

You may not qualify if:

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  • Patient's request to be withdrawn from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Martha Direnfeld, Prof.

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 22, 2017

Study Start

December 11, 2017

Primary Completion

June 1, 2019

Study Completion

November 1, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)