Novel Evaluation of Aspirated Follicular Fluid

Ovary Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999555
• Other study ID #: MMC160192-16CTIL
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2016
• Last updated: August 9, 2017
• Start date: February 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Meir Medical Center
• Contact: Anat Hershko Klement, MD
• Phone: 972549170084
• Email: anat.klement[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Ovary Inflammation

Intervention

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

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soluble Vasorin levels		24 hours post egg retrieval
Primary	Soluble Flt 1 levels		24 hours post egg retrieval
Primary	Dendritic cells quantification		24 hours post egg retrieval