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

NCT ID: NCT02342106

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-02-28

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.

Conditions

Infertility

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Poor responders

In order to define the poor response in IVF, at least two of the following three features must be present: (i) advanced maternal age or any other risk factor for poor ovarian response; (ii) a previous poor ovarian response; and (iii) an abnormal ovarian reserve test . Two episodes of poor ovarian response after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test. By definition, the term poor ovarian response refers to the ovarian response, and therefore, one stimulated cycle is considered essential for the diagnosis .

No interventions assigned to this group

Good responders

Total number of antral follicles : 22-35 Normal (good) antral count, should have an excellent response to ovarian stimulation.Likely to respond well to low doses of FSH drugs.

Very low risk for IVF cycle cancellation. Some risk for ovarian overstimulation if a Lupron trigger is not used for final egg maturation injection.

Excellent pregnancy success rates.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ofer Limonad, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center Hadera Israel

Locations

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Central Contacts

Ofer Limonad, MD

Role: CONTACT

oferlimonad@gmail.com

+972 52 5322972

Ofer Limonad, MD

Role: CONTACT

+972 4 6304248

Other Identifiers

0054-14-HYMC

Identifier Type: -

Identifier Source: org_study_id