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

• Conditions: Infertility

• Registration Number: NCT02342106
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-12-28
• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19
• Primary Completion: 2016-08
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of immature myeloid cells accumulate in the ovarian follicular fluid as measure of correlation with ovarian response to gonadotropins.	36 hours after hCG injection	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center; 🇮🇱 Hadera, Israel