Novel Evaluation of Aspirated Follicular Fluid

August 9, 2017 updated by: Anat Hershko Klement, Meir Medical Center

Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid

A molecular study of follicular fluid aspirated from ovarian follicles during routine in vitro fertilization treatment, after the eggs were identified and separated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ovarian stimulation is a routine part of in vitro fertilization treatment: this process involves an inflammatory response in the developing follicles. We still do not completely understand the complex interactions leading to the maturation of the egg and the multiple interactions of the egg with its supporting cells. In this study we will assess follicular fluid, letf over after the eggs were identified and separated, for the presence of inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and quantification of these factors, as well as their correlation with the size of the aspirated follicle is the focus of this study.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women going through a fertility/ fertility preservation indicated egg retrieval in the in vitro fertilization (IVF) unit in 'Meir medical center',
  • Patients' informed consent

Exclusion Criteria:

  • Patients refusing to take part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirated follicular fluid
Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization
Procedure: Ovum pickup
Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications
Other Names:
  • Egg retrieval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Soluble Vasorin levels
Time Frame: 24 hours post egg retrieval
24 hours post egg retrieval
Soluble Flt 1 levels
Time Frame: 24 hours post egg retrieval
24 hours post egg retrieval
Dendritic cells quantification
Time Frame: 24 hours post egg retrieval
24 hours post egg retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Collaborators

Weizmann Institute of Science

Investigators

  • Study Chair: MEIR medical center REB committee REB committee, Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 18, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC160192-16CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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