Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization

Infertility Clinical Trial

Official title:

Assessment of Myeloid Cell Constitution in the Follicular Fluid of Women Undergoing In-vitro Fertilization (IVF)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02342106
• Other study ID #: 0054-14-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: December 28, 2014
• Last updated: January 14, 2015
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: January 2015
• Source: Hillel Yaffe Medical Center
• Contact: Ofer Limonad, MD
• Phone: +972 52 5322972
• Email: oferlimonad[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The investigators will study the immune cell subpopulations in follicular fluid of patients undergoing In-Vitro Fertilization (IVF) treatment in our clinic. The investigators will corelate the presence of immature myeloid cells to the ovarian stimulation response as indicated by follicle stimulating hormone (FSH) and number of follicles or estradiol level developed on the day of human chorionic gonadotropin (hCG) administration.

Description:

The study will be an observational study using discarded material from patients undergoing IVF treatment. On the day of ovum pick up, the fluid aspirated from the first follicle in each ovary will be saved and analyzed for cellular content by fluorescence-activated cell sorter (FACS) analysis and cytokine and hormone by Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR). In addition, a total of 5cc of blood will be drawn from the patient when introducing the intravenous line for analysis of immune cell composition,hormones and cytokine levels. During the whole study number of oocytes retrieved,number of mature oocytes,number of fertilizations,implantation rates and clinical pregnancy rates will be documented as well.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women undergoing IVF treatment

• Infertility caused by one of the following : endometriosis, severe male factor, tubal occlusion, or unexplained.

Exclusion Criteria:

• An early follicular phase (day 2-4) FSH level > 20 mIU/mL

• Abnormal uterine cavity

• Any contraindication for pregnancy

• Systemic disease

• History of alcohol or drug abuse

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Israel	Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of immature myeloid cells accumulate in the ovarian follicular fluid as measure of correlation with ovarian response to gonadotropins.	After oocyte retrieval, the fluid of the largest follicle in each ovary will be collected. Follicular fluid cells will be isolated and immunostained for flow cytometry using monoclonal antibodies and the amount of immature myeloid cell will be assessed.	36 hours after hCG injection	No