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Novel Evaluation of Aspirated Follicular Fluid

Primary Purpose

Ovary Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ovum pickup
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovary Inflammation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aspirated follicular fluid

Arm Description

Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization

Outcomes

Primary Outcome Measures

Soluble Vasorin levels
Soluble Flt 1 levels
Dendritic cells quantification

Secondary Outcome Measures

Full Information

First Posted
December 18, 2016
Last Updated
August 9, 2017
Sponsor
Meir Medical Center
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT02999555
Brief Title
Novel Evaluation of Aspirated Follicular Fluid
Official Title
Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
Collaborators
Weizmann Institute of Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovary Inflammation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirated follicular fluid
Arm Type
Experimental
Arm Description
Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization
Intervention Type
Procedure
Intervention Name(s)
Ovum pickup
Other Intervention Name(s)
Egg retrieval
Intervention Description
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
Primary Outcome Measure Information:
Title
Soluble Vasorin levels
Time Frame
24 hours post egg retrieval
Title
Soluble Flt 1 levels
Time Frame
24 hours post egg retrieval
Title
Dendritic cells quantification
Time Frame
24 hours post egg retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Hershko Klement, MD
Phone
972549170084
Email
anat.klement@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MEIR medical center REB committee REB committee
Organizational Affiliation
Tel Aviv University
Official's Role
Study Chair
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anat Hershko Klement, MD
Phone
972549170084
Email
anat.klement@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11416048
Citation
Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.
Results Reference
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PubMed Identifier
16248895
Citation
Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.
Results Reference
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Novel Evaluation of Aspirated Follicular Fluid

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